tag:blogger.com,1999:blog-80863525443756053962024-03-19T01:26:00.824-07:00Quinolone Vigilance FoundationAnonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.comBlogger168125tag:blogger.com,1999:blog-8086352544375605396.post-58172658782595496092016-03-21T11:07:00.003-07:002016-03-21T11:07:42.338-07:00March 2016 Updates<div class="separator" style="clear: both; text-align: center;">
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March 2016 Updates<br />
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The Quinolone Vigilance Foundation would like to share a few updates. </div>
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We received an update on Friday from one of the attorneys representing clients involved in the peripheral neuropathy cases. As you may know, the cases have been consolidated in Minnesota under a Multidistrict Litigation (MDL) with Chief Judge John Tunheim appointed to hear the cases. The MDL allows for cases to proceed much faster through consolidation in one court and through sharing of information. </div>
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So far, there have been two status conferences in 2016 regarding the cases. They are held once a month. Status conferences are pre-trial meetings of attorneys before the judge to inform the court how the case is proceeding, what discovery has been conducted such as depositions, production of documents, etc. The next status conference is on March 15. </div>
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The Avelox eye injury cases are going to trial in the fall of 2016. </div>
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The FDA decision about the generic rule is still delayed. At last check, a decision is scheduled for July 2016 after being delayed twice. QVF continues to put pressure on the FDA to stop delaying the decision and allow generic drug makers to be held to the same standards of brand name drug makers.</div>
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We also brought in another national law firm whom are handling peripheral neuropathy cases. Information about that will be posted soon. We have confirmed that the attorneys are in good standing with the American Bar Association and we interviewed them extensively, per QVF policy. As always, we receive no funding or compensation of any kind from law firms. We provide information and updates strictly as a resource for patients. </div>
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QVF also brought in new research. We are not naming the researchers or the university at this time to protect the integrity of the project. We have confirmed that the researcher does not, and will not, take pharmaceutical money to conduct the research. QVF's policy is that we do not work with researchers who have ties to the pharmaceutical industry. We will only say that the research is an avenue that has not yet been explored. </div>
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We met with the Centers for Disease Control and Prevention March 8th after receiving security clearances. The meeting went exceedingly well and we did not need to waste any time convincing CDC representatives that fluoroquinolone toxicity is a real issue and that it is damaging and killing patients. The focus of the meeting was about solutions rather than explaining the problem. The CDC is aware that the FDA is failing patients, that Medwatch is a flawed system, and post market surveillance is non-existent. The CDC is data and evidence-driven. There is also a new reporting system in development because the Medwatch system is not reliable or accurate. </div>
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QVF is providing data to the CDC and assisting the CDC on awareness/communication campaigns and research avenues. QVF will also be looped into conference calls and meetings so that we have an equal seat at the table from a patient's perspective. This is a big step and we are very proud to have opened these avenues.</div>
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None of this could have happened without your support and we thank you for helping to make all of this possible. We have made tremendous strides and we will continue to be your voice.</div>
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Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com1tag:blogger.com,1999:blog-8086352544375605396.post-74568757238717321842016-03-21T11:05:00.001-07:002016-03-21T11:05:33.457-07:00Baron & Budd: Quinolone Vigilance Foundation Director Meets with Senators, Urges Better FDA Oversight<div class="separator" style="clear: both; text-align: center;">
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<a href="https://baronandbudd.com/protecting-whats-right/2016/03/qvf-urges-better-fda-oversight/?utm_source=twitter&utm_medium=social&utm_content=Oktopost-twitter-profile&utm_campaign=Oktopost-FLQ">Baron and Budd blog about QVF's meeting with Senators</a>:<br />
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March 10, 2016<br />
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Rachel Brummert, executive director of the Quinolone Vigilance
Foundation (QVF), recently met with U.S. Senators Thom Tillis and
Richard Burr of North Carolina to urge increased scrutiny of the U.S.
Food and Drug Administration (FDA). An <a href="http://www.wsoctv.com/news/action-9/charlotte-woman-urges-senators-to-police-fda-better/85490802" target="_blank">article</a> reporting the meeting appeared on the website of Charlotte TV station WSOC on Feb. 15.<br />
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According to the report, Brummert urged the senators to force the FDA
to not only perform more aggressive follow-ups on drugs after they are
approved, but also to form an oversight committee to watch the agency
more closely. Brummert also wants the FDA to overhaul its Medwatch
reporting program.<br />
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<strong>A Special Motivation</strong><br />
<strong> </strong><br /> Brummert became involved in the <a href="http://www.saferpills.org/" rel="nofollow" target="_blank">QVF</a>
to increase awareness of the risks of a powerful class of antibiotics
known as fluoroquinolones. She has first-hand experience of those risks,
as she has had numerous tendon ruptures and even heart problems after
taking a fluoroquinolone more than a decade ago.<br />
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These antibiotics, including Levaquin, <a href="https://baronandbudd.com/mydrugjustice/avelox-lawsuit/" rel="nofollow">Avelox</a>
and others, have been over-prescribed for several years. In many
instances they are prescribed for relatively minor ailments such as
sinus and ear infections even though they are designed to deal with much
more severe infections.<br />
One of the most serious complications
linked to fluoroquinolones is a condition known as peripheral
neuropathy, which can lead to permanent nerve damage. It can occur at
any time after taking a fluoroquinolone. In fact, symptoms can begin
within just a few days of taking the drug.<br />
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The disease causes damage to the nerves that help the brain and spinal
cord communicate with the rest of the body. When this communication is
interrupted, the results can be debilitating. They include a loss of
reflexes, shooting pain, and a reduced sensation to pain, touch and
temperatures. In extreme cases, paralysis can occur. <br />
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Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-40684222164973913982016-03-21T11:00:00.003-07:002016-03-21T11:00:31.487-07:00QVF Goes to Atlanta, Georgia<div class="separator" style="clear: both; text-align: center;">
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QVF executive director Rachel Brummert and QVF ambassador Jonathan Furman traveled to Atlanta, Georgia to meet with the Centers for Disease Control and Prevention, and for a television interview with WSB-TV. Joining them was Jeff Stephens, a gentleman disabled after taking Levaquin. <br />
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Following the CDC meeting, they went to WSB-TV to do a television interview.<br />
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<br />
QVF video about our Atlanta trip:<a href="https://www.youtube.com/watch?v=zfmFW37aR1Q"> https://www.youtube.com/watch?v=zfmFW37aR1Q</a>Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-18522245757958625822016-03-21T10:40:00.001-07:002016-03-21T10:40:19.992-07:00Consumer Reports: Fluoroquinolones Are Too Risky for Common Infections<div class="separator" style="clear: both; text-align: center;">
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<br />
<h1 class="headline">
Fluoroquinolones Are Too Risky for Common Infections</h1>
<div class="additional-headline-section">
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<div class="subhead col-xs-12 col-sm-12 col-md-12 col-lg-12 ">
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<h2 class="subhead">
An FDA panel says popular antibiotics such as
Cipro are overprescribed and should have stronger warnings about
dangerous side effects</h2>
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<div class="byline col-xs-5 col-sm-4 col-md-4 col-lg-3 author-and-date">
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<span itemprop="author">By Teresa Carr</span>
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<div class="date parbase date-par">
<time class="published-date" datetime="2016-03-07">
March 07, 2016 </time></div>
<div class="date parbase date-par">
<time class="published-date" datetime="2016-03-07"> </time></div>
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Last November, Rachel Brummert, 45, of
Charlotte, North Carolina, stood before a panel of experts and described
the ever-worsening series of health problems, including 10 ruptured
tendons and progressive nerve damage, she’s suffered as side effects of
taking the antibiotic Levaquin, a type of fluoroquinolone, for a
suspected sinus infection in 2006.<br />
<br />
The Food and Drug Administration convened the panel to consider
whether the official drug labels for fluoroquinolones, a group of
antibiotics that includes drugs such as Cipro and Levaquin, should be
changed to more clearly spell out their risks and <a href="http://www.consumerreports.org/cro/2014/03/why-you-should-be-worried-about-antibiotics/index.htm" target="_blank">discourage overuse</a>.
Brummert, the executive director of the Quinolone Vigilance Foundation,
was one of more than 30 people who spoke during the open public hearing
portion of the meeting about how the drugs had an <a href="http://www.consumerreports.org/cro/news/2013/09/antiibiotic-misuse-kills-thousands-harms-millions/index.htm" target="_blank">impact on their lives</a>.<br />
“I am living proof that the risks in using a fluorquinolone to treat
a routine infection far outweighs the benefits,” Brummert says.</div>
</div>
<time class="published-date" datetime="2016-03-07"> </time></div>
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After reviewing the evidence, the
21-member FDA panel agreed. They voted overwhelmingly that, in most
cases, the benefit of fluoroquinolones to treat three common
illnesses—bacterial sinus infections, urinary tract infections, and some
forms of bronchitis in people with chronic lung disease—was outweighed
by the risk of rare, but serious side effects, including irregular
heartbeats, depression, nerve damage, ruptured tendons, and seizures.<br />
<br />
Currently, those three illnesses account for nearly one-third of all
fluoroquinolones prescribed outside of hospitals in the U.S. according
to data presented by Janssen Pharmaceuticals, makers of Levaquin, at the
FDA meeting.<br />
<br />
While the fluroquinolones are essential for treating serious
infections such as anthrax, the FDA panel members noted that they are
overprescribed for common infections where other treatments would work
just as well with less risk. They called on the FDA to strengthen
labeled warnings and clarify when the drugs—should—and <a href="http://www.consumerreports.org/cro/2014/03/when-you-think-you-need-antibiotics-but-really-don-t/index.htm" target="_blank">should not</a>—be used.</div>
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<div class="section text textsection">
<h2>
Rampant Overprescribing</h2>
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Over the last 30 years, the FDA has
approved five fluroquinolone antibiotics to treat one or more of three
illnesses considered by the panel: ciprofloxacin (Cipro), levofloxacin
(Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), and gemifloxacin
(Factive). All are also available as generics.<br />
Much of the evidence on the risks of the drugs emerged after the
drugs were on the market and used by millions of patients. While medical
organizations such as the Infectious Diseases Society of America have
updated their guidelines to advise against prescribing fluoroquinolones
for milder garden-variety infections—including most cases of bronchitis,
sinus infections, and urinary tract infections—many doctors haven’t
gotten the message. That's likely because these powerful antibiotics
work against a wide variety of bacteria, says Lindsey R. Baden, M.D., an
infectious disease physician at Brigham and Women’s Hospital in Boston,
Massachusetts, an associate professor at Harvard Medical School, and a
member of the FDA panel. That can lead to overprescribing.</div>
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<div class="section text">
<div class="text-container">
“Fluoroquinolones play an important role
in treating serious infections such as those caused by bacteria that are
resistant to other types of antibiotics,” says Baden. But in the case
of less severe illnesses such as a mild bacterial sinus infection or
uncomplicated bladder infection, the drugs “should typically be reserved
for second-line or even third-line treatment after other antibiotics
have failed,” says Baden.<br />
<br />
<div class="section text bulletssection textsection">
<h2>
When to Say 'No' to Cipro and Similar Drugs</h2>
<div class="text-container">
Below we’ve listed three types of
infections where fluoroquinolones are often not the best first choice
for treatment along with our medical advisers’ advice about what to do
instead.<br />
<ul>
<li><b><a href="http://www.consumerreports.org/drugs/for-sinus-infections--don-t-rush-to-an-antibiotic/" target="_blank">Sinus infections</a>. “</b>The
vast majority of sinus infections are caused by a virus, not a bacteria
and antibiotics don’t work against viruses,” says Baden. Even if
bacteria are responsible, the infection will typically clear up on it’s
own in a week or so. An antibiotic such as amoxicillin may be warranted
if your symptoms last longer than a week, start to improve and then
worsen, or are very severe—accompanied by a fever of 101.5 or higher,
for example, or extreme pain and tenderness over your sinuses. For more
information see <a href="https://www.consumerreports.org/content/dam/cro/news_articles/health/PDFs/ChoosingWiselySinisitusAAAAIlow.pdf" target="_blank">Choosing Wisely recommendations</a> from the American Academy of Allergy, Asthma, and Immunology.</li>
<li><b>Urinary tract infections (UTIs).</b> If you have symptoms of a
urinary tract infection such as having to urinate frequently, pain or
burning when you go, cloudy or bloody urine, and a fever, you may need
an antibiotic to treat the infection. Several types of antibiotics are
effective against uncomplicated bladder infections; fluoroquinolones are
typically only necessary if the infection is resistant to other
antibiotics or has spread to the kidneys. Note that people aged 65 and
older often have bacteria in their urine, but do not need to be tested
or treated for a UTI unless they have symptoms. For more information see
<a href="http://www.choosingwisely.org/patient-resources/antibiotics-for-urinary-tract-infections-in-older-people/" target="_blank">Choosing Wisely recommendations</a> from the American Geriatric Society.</li>
<li><b><a href="http://www.consumerreports.org/drugs/why-your-doctor-should-not-give-you-antibiotics-for-your-respiratory-infection/" target="_blank">Bronchitis</a>.</b>
As with sinus infections, most cases of bronchitis, or chest colds, are
caused by a virus and are not helped by taking an antibiotic. (Read
our <a href="http://www.consumerreports.org/drugs/why-your-doctor-should-not-give-you-antibiotics-for-your-respiratory-infection/" target="_blank">advice</a>
on what to do ease symptoms while your body fights the infection.) One
exception: patients with chronic obstructive pulmonary disease (COPD), a
condition that causes difficulty breathing, may benefit from
antibiotics if they develop symptoms severe enough to require
hospitalization. In that case, the best choice of drug depends on the
several factors, including which bacteria are prevalent in your area.
For more information on using antibiotics to treat respiratory illness
in children see <a href="http://www.choosingwisely.org/patient-resources/antibiotics-for-respiratory-illness-in-children/" target="_blank">Choosing Wisely recommendations</a> from the American Academy of Pediatrics.</li>
</ul>
</div>
</div>
<div class="section text textsection">
<h2>
All Antibiotics Have Risk</h2>
<div class="text-container">
Brummert says she hopes that the FDA will
act on the advisory panel’s recommendations. “Curbing unnecessary
prescribing of fluoroquinolones could save thousands of Americans from
needless suffering,” she says.<br />
<br />
Baden points out that all antibiotics—not just fluoroquinolones—should be <a href="http://www.consumerreports.org/cro/2014/03/why-you-should-be-worried-about-antibiotics/index.htm" target="_blank">used more thoughtfully</a>.<br />
“Really, I think the labels for all antibiotics should be
strengthened to remind doctors and patients that when the drug is
unwarranted, prescribing it has no benefit and exposes patients to
needless risk, however small that risk may be,” says Baden. “Antibiotics
are overused; as a community we need to be having these conversations
about better prescribing based on the balance of benefits to harms.”</div>
</div>
<div class="section text">
<div class="text-container">
<b>Editor's Note: </b>This article and
related materials are made possible by a grant from the state Attorney
General Consumer and Prescriber Education Grant Program, which is funded
by the multistate settlement of consumer-fraud claims regarding the
marketing of the prescription drug Neurontin (gabapentin).</div>
</div>
</div>
</div>
<time class="published-date" datetime="2016-03-07"> </time>
</div>
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<h1 class="headline">
</h1>
<h1 class="headline">
</h1>
Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-55953736660166707882016-03-21T10:34:00.001-07:002016-03-21T10:34:08.004-07:00FDA Commissioner nominee Dr. Robert Califf a Threat to Patient Safety<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjudVZvgXybYfSRFB0NBU1KPFefwLYjwsjQMbnMHZEiLWm39L3eAngW2h8yEOTJFXxQiGxJhb8ZPkxHhNlZr250Nfs2s8MVpJ2mFw04YHF1AGz5pojhn7_UB_FHESkR17_bzFW4ZM__uSU/s1600/letterhead.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="117" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjudVZvgXybYfSRFB0NBU1KPFefwLYjwsjQMbnMHZEiLWm39L3eAngW2h8yEOTJFXxQiGxJhb8ZPkxHhNlZr250Nfs2s8MVpJ2mFw04YHF1AGz5pojhn7_UB_FHESkR17_bzFW4ZM__uSU/s320/letterhead.jpg" width="320" /></a></div>
<span style="font-size: large;">FDA Commissioner nominee Dr. Robert Califf a Threat to Patient Safety</span><br />
<br />
<div class="_2cuy _3dgx _2vxa">
On February 22, 2016, the US Senate will hold a cloture vote for the Senate confirmation of Dr. Robert Califf as Commissioner of the Food and Drug Administration (FDA).</div>
<div class="_2cuy _3dgx _2vxa">
The Quinolone Vigilance Foundation sent the following letter to US. Senator Richard Burr, who is on the HELP Committee. </div>
<div class="_2cuy _3dgx _2vxa">
As you may recall, QVF met with Senator Burr’s office in Washington, DC on February 3. One of many things QVF brought up was fluoroquinolones, failure on the part of the FDA, patient safety and preventable medical harm, and the possible confirmation of Dr. Califf.</div>
<div class="_2cuy _3dgx _2vxa">
<br /></div>
<div class="_2cuy _3dgx _2vxa">
<br /></div>
<div class="_2cuy _3dgx _2vxa">
February 11, 2016</div>
<div class="_2cuy _3dgx _2vxa">
<br /></div>
<div class="_2cuy _3dgx _2vxa">
Senator Richard Burr</div>
<div class="_2cuy _3dgx _2vxa">
217 Russell Senate Office Building</div>
<div class="_2cuy _3dgx _2vxa">
Washington, DC 20510 </div>
<div class="_2cuy _3dgx _2vxa">
</div>
<div class="_2cuy _3dgx _2vxa">
Dear Senator Richard Burr,</div>
<div class="_2cuy _3dgx _2vxa">
</div>
<div class="_2cuy _3dgx _2vxa">
As a patient who has been irrevocably harmed by a dangerous fluoroquinolone antibiotic, and as the Executive Director of the Quinolone Vigilance Foundation, I am writing to express deep concerns over the impending cloture vote on February 22, 2016 for the Senate confirmation of Dr. Robert Califf as Commissioner of the Food and Drug Administration (FDA).</div>
<div class="_2cuy _3dgx _2vxa">
</div>
<div class="_2cuy _3dgx _2vxa">
Three United States Senators have placed a hold on the Senate confirmation of Dr. Califf. Despite that, the Senators who have said they will block such a vote have done so, not out of political contentiousness, but rather from grave concerns over Dr. Califf’s ability to provide the kind of leadership that the FDA needs to protect the health and safety of the American people. </div>
<div class="_2cuy _3dgx _2vxa">
The New York Times recently stated, “Califf has ‘deeper ties to the pharmaceutical industry than any F.D.A. commissioner in recent memory.’ The threats to patient safety are enormous and alarming. </div>
<div class="_2cuy _3dgx _2vxa">
A Xarelto study led by Dr. Califf came under sharp criticism by the FDA as having a built-in bias in favor of this new, more expensive blood thinner. Although eventually approved, Xarelto is now the subject of mass litigation for causing untold injury and death. </div>
<div class="_2cuy _3dgx _2vxa">
</div>
<div class="_2cuy _3dgx _2vxa">
Sources: </div>
<div class="_2cuy _3dgx _2vxa">
<a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fwww.pogo.org%2Fblog%2F2015%2F11%2Ffda-nominee-robert-califf-led-faulted-fda-trial.html&h=GAQHGMVyJ&s=1" rel="nofollow" target="_blank">http://www.pogo.org/blog/2015/11/fd...</a></div>
<div class="_2cuy _3dgx _2vxa">
<a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fcardiobrief.org%2F2015%2F11%2F30%2Fnew-questions-raised-about-rocket-af-pivotal-xarelto-trial-chaired-by-califf&h=8AQE6y5hu&s=1" rel="nofollow" target="_blank">http://cardiobrief.org/2015/11/30/n...</a></div>
<div class="_2cuy _3dgx _2vxa">
</div>
<div class="_2cuy _3dgx _2vxa">
Dr. Califf has said that he will not lower FDA standards. Yet a recent New York Times editorial states that “In 2014, Dr. Califf gave a speech to researchers, lawyers and industry experts in which he described regulation as a 'barrier' to biomedical innovation. He also helped author a series of papers which were critical of the FDA, and had his name removed from those papers in close proximity to when he was nominated for the Commissioner position. Dr. Califf has recently come under scrutiny for providing the Senate HELP Committee members with questionable answers.</div>
<div class="_2cuy _3dgx _2vxa">
</div>
<div class="_2cuy _3dgx _2vxa">
Sources: </div>
<div class="_2cuy _3dgx _2vxa">
<a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fwww.raps.org%2FRegulatory-Focus%2FNews%2F2016%2F01%2F11%2F23872%2FCaliff-Vows-Not-to-Lower-or-Remove-FDA-Regulations%2F&h=VAQEFoJ2H&s=1" rel="nofollow" target="_blank">http://www.raps.org/Regulatory-Focu...</a> </div>
<div class="_2cuy _3dgx _2vxa">
<a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fwww.pogo.org%2Fblog%2F2016%2F02%2Ffda-nominee-califf-gave-questionable-answers-senate.html&h=vAQHHoyZN&s=1" rel="nofollow" target="_blank">http://www.pogo.org/blog/2016/02/fd...</a> </div>
<div class="_2cuy _3dgx _2vxa">
</div>
<div class="_2cuy _3dgx _2vxa">
If Dr. Califf is confirmed, there is grave concern that he will jeopardize patient safety and further lower the integrity of the FDA review process. Patients need a Commissioner who will provide reasonable assurance of the safety and efficacy of our drugs and devices through the gold standard of double-blind, human clinical studies. Therefore, I and other patients who have been harmed by toxic fluoroquinolone antibiotics, call on the Senate to prioritize patients above industry groups, to put the integrity of the scientific process above profits, and decline to confirm the nomination of Dr. Robert Califf as Commissioner of the FDA.</div>
<div class="_2cuy _3dgx _2vxa">
<br /></div>
<div class="_2cuy _3dgx _2vxa">
Respectfully,</div>
<div class="_2cuy _3dgx _2vxa">
Rachel Brummert, Executive Director</div>
<div class="_2cuy _3dgx _2vxa">
Quinolone Vigilance Foundation</div>
<div class="_2cuy _3dgx _2vxa">
<a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fwww.SaferPills.org%2F&h=WAQGPYweT&s=1" rel="nofollow" target="_blank">www.SaferPills.org</a></div>
<div class="_2cuy _3dgx _2vxa">
Charlotte, North Carolina 28213</div>
<br />
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<br />Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-8848527584604482032016-03-21T10:27:00.003-07:002016-03-21T10:27:36.931-07:00QVF Goes to Washington, DC- February 1-3, 2016<div class="separator" style="clear: both; text-align: center;">
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Rachel Brummert, executive director of QVF, and Jonathan Furman, QVF ambassador, went to Washington, DC February 1-3.<br />
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On February 1, they attended a dinner and met 40 patient safety advocates from across the country.<br />
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February 2 was a busy day. Ms Brummert and Mr Furman attended the Safe Patient Summit. They learned a lot, were given access to resources, listened to guest speakers, participated in round table discussions, and networked with journalists and Public Citizen.<br />
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February 3, Mr Furman and Ms Brummert met with legislators in the United States Senate and United States House of Representatives. They were also interviewed for two television news stories which aired in Charlotte, North Carolina, and Richmond, Virginia.<br />
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WSOC-TV interview: <a href="http://www.wsoctv.com/news/action-9/charlotte-woman-urges-senators-to-police-fda-better/85490802">http://www.wsoctv.com/news/action-9/charlotte-woman-urges-senators-to-police-fda-better/85490802 </a><br />
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WRIC-TV interview: <a href="http://wric.com/2016/02/07/federal-lawsuit-filed-against-former-fda-commissioner/">http://wric.com/2016/02/07/federal-lawsuit-filed-against-former-fda-commissioner/ </a><br />
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After their meetings with legislators, they attended a vigil for those harmed and killed by medical harm. It was filmed by documentary filmmakers.<br />
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QVF video about our visit to Washington, DC: <a href="https://www.youtube.com/watch?v=0Qm7M4KpQq0">https://www.youtube.com/watch?v=0Qm7M4KpQq0</a><br />
Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com1tag:blogger.com,1999:blog-8086352544375605396.post-59903890262941825492016-03-21T09:22:00.003-07:002016-03-21T09:23:20.636-07:00Guest blog for Consumers Union- A Cautionary Tale: Dangers of Antibiotic Overuse<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiLTu3B4jgwrDSZDip95VWEkb4spo-lvQXuHa0hXY8sxH2AvuBjdu7HPQhxsToE9DzIf4Awwry3aVtOwk-IPYw91sT4SbiOblun5fN3raBDSGrejMF_3A7NLs07rwI_xuy2FleLg37YEuo/s1600/letterhead.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="117" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiLTu3B4jgwrDSZDip95VWEkb4spo-lvQXuHa0hXY8sxH2AvuBjdu7HPQhxsToE9DzIf4Awwry3aVtOwk-IPYw91sT4SbiOblun5fN3raBDSGrejMF_3A7NLs07rwI_xuy2FleLg37YEuo/s320/letterhead.jpg" width="320" /></a></div>
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<br />
Rachel Brummert, executive director of the Quinolone Vigilance Foundation wrote a guest blog for Consumer's Union.<br />
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<a href="http://safepatientproject.org/posts/5609-a-cautionary-tale-dangers-of-antibiotic-overuse">http://safepatientproject.org/posts/5609-a-cautionary-tale-dangers-of-antibiotic-overuse </a><br />
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January 5, 2016 <br />
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<h2>
<a href="http://safepatientproject.org/posts/5609-a-cautionary-tale-dangers-of-antibiotic-overuse" rel="bookmark" title="A Cautionary Tale: Dangers of Antibiotic Overuse">A Cautionary Tale: Dangers of Antibiotic Overuse</a></h2>
<h2>
</h2>
<i>Guest post by Rachel Brummert, Executive Director, <a href="http://www.saferpills.org/">Quinolone Vigilance Foundation</a></i><br />
<i> <a href="mailto:rachel@saferpills.org">rachel@saferpills.org</a></i><br />
<br />
Patients seeking relief from a sinus infection, uncomplicated urinary
tract infection, or bronchitis should never become injured or disabled
from medications that are supposed to help them.<br />
But that is exactly what happens to millions of people worldwide <a href="http://wric.com/2015/04/21/8news-investigates-could-this-antibiotic-permanently-damage-your-health/">when they are prescribed a powerful fluoroquinolone antibiotic like Cipro</a>
(ciprofloxacin), Levaquin (levofloxacin), or Avelox (moxifloxacin) for
routine infections which do not need their strength and for which there
are safer alternatives.<br />
<br />
Fluoroquinolones are a class of broad spectrum antibiotics that are
incredibly powerful with the capability to save lives when used
appropriately as a treatment of last resort for life-threatening
bacterial infections like anthrax. But these antibiotics also have equal
power to destroy lives when they are inappropriately prescribed for
routine infections, which don’t need their strength. Prescribing an
antibiotic strong enough to treat anthrax for a simple infection is like
detonating an atomic bomb to kill a mosquito. Fluoroquinolone
antibiotics are associated with severe adverse reactions, which may be
permanent and life-threatening.<br />
<br />
As the number of prescriptions for fluoroquinolone tablets, IV, eye drops, and ear drops have increased, so have the number of <a href="http://www.fda.gov/Safety/MedWatch/">adverse reactions reported to the FDA</a>.
These adverse reactions encompass several body systems including the
peripheral, autonomic, and central nervous systems, psychiatric,
cardiovascular, musculoskeletal system, and more.<br />
<br />
The FDA is taking notice of this. The agency <a href="http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm">has issued a “black box” warning</a> to prescribers of the drug. And in a recent review, the <a href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM467383.pdf">FDA refers to this constellation of symptoms in previously healthy individuals as “fluoroquinolone-associated disability”.</a><br />
<br />
That is exactly what happened to me. I went to my doctor for
treatment of a routine sinus infection and instead I was inappropriately
prescribed an antibiotic that has disabled me. According to the CDC, <a href="http://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf">up to 50% of all the antibiotics prescribed for people are not needed or are not optimally effective as prescribed.</a><br />
<br />
On November 5, 2015, I was honored to testify at the <a href="http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/ucm424449.htm">FDA Joint Meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.</a>
The panel discussed the risk/benefit ratio of fluoroquinolone
antibacterial drugs for the treatment of routine infections. I shared my
story of how I was an otherwise healthy individual who was prescribed
Levaquin for a routine sinus infection in 2006 and became disabled with
ten tendon ruptures, peripheral neuropathy, cardiac problems, and a
progressive neurodegenerative disorder from which I will never recover.
My sinus infection would have resolved had I been prescribed a safer
alternative and I would not have been exposed to the relatively
disproportionate risks of known fluoroquinolone-associated injury.<br />
<br />
The hearing took place at the FDA White Oak Campus in Silver Spring, Maryland, the same building and conference room as the <a href="http://quinolonevigilancefoundation.blogspot.com/2015/03/fda-hearing-march-27-2015.html">Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Hearing</a> on March 27, 2015 at which I testified about how the <a href="http://www.supremecourt.gov/opinions/10pdf/09-993.pdf">Pliva v Mensing Supreme Court decision</a>
prevents victims harmed by generic fluoroquinolones from pursuing legal
action against their makers and how patients are being harmed
unnecessarily because generic drug makers are not required to update the
safety information on generic drugs.<br />
<br />
At the November FDA hearing, 35 people, including me, testified in
front of the twenty-one member FDA advisory panel, each sharing their
emotional, gut-wrenching stories of how fluoroquinolone antibiotics
caused them, or someone they love, irreparable harm. Among them was a
woman who lost her son, a man who lost his brother, and dozens of
victims who once led healthy, productive lives and can no longer enjoy a
reasonable quality of life.<br />
<br />
The advisory panel agreed that the risks outweigh the benefits when
fluoroquinolone antibiotics are inappropriately prescribed for routine
infections and they voted 21-0 for a label revision on sinusitis, 20-1
for UTIs, and 18-2 with one abstention for bronchitis.<br />
<br />
Advocating for victims of fluoroquinolone antibiotics, promoting
patient safety, educating patients and the medical community, and
engaging in research is our primary goal at the <a href="http://www.saferpills.org/">Quinolone Vigilance Foundation</a>,
and we applaud the FDA advisory panel for taking steps in the right
direction to protect patients from preventable harm. By recommending
limiting fluoroquinolone antibiotics to life-threatening infections and
not prescribing them for routine infections, patients will be protected
from life-long injury and disability, and it will help combat antibiotic
resistance, a growing world-wide epidemic. These are steps in the right
direction because a preventable problem is a fixable problem.<br />
<h2>
</h2>
Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com1tag:blogger.com,1999:blog-8086352544375605396.post-25646023170748023822015-12-19T13:50:00.004-08:002015-12-19T13:50:51.376-08:00QVF Year in Review 2015<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiIovalUB0JU1Tsf69fl7-kN5cxDYNORRSeXZ1giBm-x-uxoIOhrCBKPexIE8I3a73f3OCLw0NupdEcAHv667xxT0eAqtYHTh7rRMX02WEZayFvuJ97nRe0-AwqfnLpcLqBxPxX9Ih5tu4/s1600/letterhead.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="117" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiIovalUB0JU1Tsf69fl7-kN5cxDYNORRSeXZ1giBm-x-uxoIOhrCBKPexIE8I3a73f3OCLw0NupdEcAHv667xxT0eAqtYHTh7rRMX02WEZayFvuJ97nRe0-AwqfnLpcLqBxPxX9Ih5tu4/s320/letterhead.jpg" width="320" /></a></div>
<div class="_2cuy _3dgx _2vxa">
QVF had a busy and productive year in 2015.</div>
<div class="_2cuy _3dgx _2vxa">
In January, Executive Director Rachel Brummert and Assistant Director Donna Schutz were interviewed by Health Cosmos.<a href="http://www.healthcosmos.com/community/fluoroquinolone_toxicity_41"> http://www.healthcosmos.com/community/fluoroquinolone_toxicity_41</a>. QVF will be interviewed for a second interview in the coming weeks. </div>
<div class="_2cuy _3dgx _2vxa">
</div>
<div class="_2cuy _3dgx _2vxa">
In February, investigative reporter Jim Strickland and ABC2 in Atlanta,
Georgia airs a story about the dangers of Levaquin. Featured are QVF
Duluth, Georgia Ambassador Kathy Dannelly whose husband Chris died after
taking Levaquin, as well as Quinolone Vigilance Foundation Assistant
Director Donna Schutz and her fiancee Jeff Stephens, who is disabled
after taking Levaquin: <a href="http://www.wsbtv.com/videos/news/channel-2-investigates-complaints-about-popular/vDDZZS/">http://www.wsbtv.com/videos/news/channel-2-investigates-complaints-about-popular/vDDZZS/</a>. The station told us that the original story is the biggest story in the
last two years for the station, and that it was viewed on social media
over 5 million times. To date, it is the most shared news story about
Fluoroquinolone Toxicity. </div>
<div class="_2cuy _3dgx _2vxa">
</div>
<div class="_2cuy _3dgx _2vxa">
The station ran a follow-up stories immediately following the original air date of February 2. <a href="http://www.wsbtv.com/news/news/local/patients-suffer-devastating-side-effects-popular-a/nj4Br/">http://www.wsbtv.com/news/news/local/patients-suffer-devastating-side-effects-popular-a/nj4Br/</a> and <a href="http://www.wsbtv.com/videos/news/another-widow-says-medication-killed-her-husband/vDD6mw/">http://www.wsbtv.com/videos/news/another-widow-says-medication-killed-her-husband/vDD6mw/</a>.</div>
<div class="_2cuy _3dgx _2vxa">
<br /></div>
<div class="_2cuy _3dgx _2vxa">
The following week, QVF Assistant Director Donna Schutz is featured in a radio show about Fluoroquinolone Toxicity<a href="http://www.progressivemedicalcenter.com/antibiotics-concerns/"> http://www.progressivemedicalcenter.com/antibiotics-concerns/</a>. Progressive Medical Center is the only medical center in the country
that specifically treats Fluoroquinolone Toxicity and we appreciate all
they do.</div>
<div class="_2cuy _3dgx _2vxa">
</div>
<div class="_2cuy _3dgx _2vxa">
On March 3 the Quinolone Vigilance Foundation honored WSB-TV Atlanta
reporter Jim Strickland and his team from WSB-TV. Pictured are Producer
Kellie Burkett, Jim Strickland and Photographer/Editor Leah Dunn who
worked very hard on the Atlanta news stories which featured QVF
Ambassador Kathy Dannelly, QVF Assistant Director Donna Schutz, and
floxie Jeff Stephens. Kathy Dannelly began working with WSB-TV on the
story June 2013. Reporter Jim Strickland began working with us in
October 2014. The original news segment was filmed in December 2014.
Kellie, Jim, and Leah did an excellent job and it was a pleasure working
with them.</div>
<div class="_2cuy _3dgx _2vxa">
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<div class="_2cuy _3dgx _2vxa">
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<div class="_2cuy _3dgx _2vxa">
Also in March, QVF's Vice President Chris Butler set up and was interviewed for a news story: <a href="http://www.kctv5.com/story/28170151/fda-evaluates-popular-antibiotic-that-patients-say-makes-them-sicker">http://www.kctv5.com/story/28170151/fda-evaluates-popular-antibiotic-that-patients-say-makes-them-sicker</a> </div>
<div class="_2cuy _3dgx _2vxa">
</div>
<div class="_2cuy _3dgx _2vxa">
On March 13th, the Quinolone Vigilance Foundation held a fundraiser at
the Grog and Tankard Sports Bar & Grill in Stafford, Virginia.
Executive Director Rachel Brummert and QVF Ambassador Jonathan Furman
were on hand to talk about our work and educate the patrons and we
raised a lot of awareness. <a href="https://www.youtube.com/watch?v=8E01kFyqXDA">https://www.youtube.com/watch?v=8E01kFyqXDA</a> . We thank Dark Anubis Promotions, Chris Welborn, and the bands Helafyde,
Echoes of Solitude, goddess Crow, Service of Shadows, and ZFL for
playing the event. <a href="http://quinolonevigilancefoundation.blogspot.com/2015/03/qvf-fundraiser-31315.html">http://quinolonevigilancefoundation.blogspot.com/2015/03/qvf-fundraiser-31315.html . </a></div>
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<br />
March 27, QVF Executive Director Rachel Brummert testified at an FDA
Hearing in Silver Spring, Maryland. Joining her were Lisa Bloomquist and
QVF Ambassador Jonathan Furman. Rachel and Lisa testified in front of
the FDA panel at the Supplemental Applications Proposing Labeling
Changes for Approved Drugs and Biological Products Hearing. The FDA
proposed a rule that would hold generic drug makers accountable for the
damage their products cause and make them update their safety
information. Due to the Pliva v Mensing Supreme Court decision, patients
who are injured by generic medications cannot sue the drug maker, and
generic drug makers are also not required to update safety information.
The FDA was to make a decision in September 2015, and it was postponed
to February 2016 and then to July 2016. (More on that later)<br />
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You can hear their testimony:</div>
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Lisa is the first speaker- <a href="https://collaboration.fda.gov/p4vtitcjbcb/?launcher=false&fcsContent=true&pbMode=normal">https://collaboration.fda.gov/p4vtitcjbcb/?launcher=false&fcsContent=true&pbMode=normal </a></div>
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Rachel is the third speaker- <a href="https://collaboration.fda.gov/p16w66yyjfa/?launcher=false&fcsContent=true&pbMode=normal">https://collaboration.fda.gov/p16w66yyjfa/?launcher=false&fcsContent=true&pbMode=normal</a> </div>
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Rounding out March, QVF's Italy Ambassador Andrea Favero was featured in a newspaper article in Italy about fluoroquinolones. </div>
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The same day as the QVF fundraiser in March, Executive Director Rachel
Brummert and QVF Ambassador Jonathan Furman were interviewed in
Fredricksburg, Virginia by WRIC-TV reporter Kerri O'Brien. It aired on
April 23. The first video is the short version and the second video is
the full version: <a href="http://wric.com/2015/04/21/8news-investigates-could-this-antibiotic-permanently-damage-your-health/">http://wric.com/2015/04/21/8news-investigates-could-this-antibiotic-permanently-damage-your-health/</a></div>
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At the end of April, Rachel Brummert was interviewed by Dr. Joe Hudak
and Dr. Chris Burfield for their podcast Journey to Wellness. <a href="http://hwcdn.libsyn.com/p/d/a/2/da255c17bcd3794a/013__Edison_NJ_Chiropractor.mp3?c_id=8894298&expiration=1450560766&hwt=1b4c3253c536b1fdf06baed7910a652a">http://hwcdn.libsyn.com/p/d/a/2/da255c17bcd3794a/013__Edison_NJ_Chiropractor.mp3?c_id=8894298&expiration=1450560766&hwt=1b4c3253c536b1fdf06baed7910a652a</a></div>
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June 13, 2015- QVF Executive Director Rachel Brummert and Treasurer
Christina Manthos-Sorrell met up for a lovely visit and to discuss
future QVF projects </div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjbbJn3aGh4vqNN7BRwm8vaHVDK-qDG24tRPp1uHC_nU9QQmuIV5f1xXzjq-P4yky4Zq3uW2lFiCDX2Q7mV_X-oJ4KcVWoxqro1uSOkI24F9rVofZ6-y2Av-d8LNeazzYzsEaRA_NbLOg8/s1600/12347826_1058886334130240_861040860501781014_n.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="293" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjbbJn3aGh4vqNN7BRwm8vaHVDK-qDG24tRPp1uHC_nU9QQmuIV5f1xXzjq-P4yky4Zq3uW2lFiCDX2Q7mV_X-oJ4KcVWoxqro1uSOkI24F9rVofZ6-y2Av-d8LNeazzYzsEaRA_NbLOg8/s320/12347826_1058886334130240_861040860501781014_n.jpg" width="320" /></a></div>
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Around mid-June, Rachel Brummert was approached by actor, author, and
international speaker Rivedal and asked her to participate in the
i'mPossible Project. Rachel is one of 50 authors who share their
stories. The book will be released January 13. <a href="http://www.bizjournals.com/prnewswire/press_releases/2015/09/16/MN02683"> http://www.bizjournals.com/prnewswire/press_releases/2015/09/16/MN02683</a>. Per Rachel's request with the publisher, 100% of the proceeds from her
portion of the book will be donated to QVF. Her story in the book has
already raised awareness; people who have reviewed the proof copy of the
book and some of the other authors have contacted her about her story
and how they have been affected too. </div>
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On June 16, Rachel Brummert met Bob Grozier's family- his sister and
mother. They had a wonderful visit. For those who don't know, Bob
Grozier passed away in June 2014, 12 years after he suffered adverse
reactions to Cipro. With the Grozier's blessing, QVF produced a video
about his life and death. Bob was a staunch advocate and he helped
untold numbers of victims despite his own suffering. We miss him very
much. </div>
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<div class="_2cuy _3dgx _2vxa">
Facebook: <a href="https://www.facebook.com/video.php?v=978187655533442&set=vb.207825862569629&type=3&theater">https://www.facebook.com/video.php?v=978187655533442&set=vb.207825862569629&type=3&theater</a></div>
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YouTube: <a href="https://www.youtube.com/watch?v=1l0iZNU-JHc">https://www.youtube.com/watch?v=1l0iZNU-JHc </a></div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgjugNJaxMn1cXYzT3ohba5_wXqB5jFkqXTEY5e-pxHnf55tjKj7OjpMiWIuthHZoUstTbVd5vMUyfGk3WWOrKVo0XnandrycaXOGY0mDTwPWp0znBzWpI-CiWX2CmsfxV_U9w4EgNh4yM/s1600/12360409_1058890114129862_4442119870980207004_n.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgjugNJaxMn1cXYzT3ohba5_wXqB5jFkqXTEY5e-pxHnf55tjKj7OjpMiWIuthHZoUstTbVd5vMUyfGk3WWOrKVo0XnandrycaXOGY0mDTwPWp0znBzWpI-CiWX2CmsfxV_U9w4EgNh4yM/s320/12360409_1058890114129862_4442119870980207004_n.jpg" width="180" /></a></div>
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QVF also produced a video called the Real Cost of Fluoroquinolone Antibiotics.<br />
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Facebook: <a href="https://www.facebook.com/video.php?v=976006515751556&set=vb.207825862569629&type=3&theater">https://www.facebook.com/video.php?v=976006515751556&set=vb.207825862569629&type=3&theater</a></div>
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YouTube: <a href="https://www.youtube.com/watch?v=4UkAwJFyKNA">https://www.youtube.com/watch?v=4UkAwJFyKNA</a><br />
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In July, QVF relocated to beautiful North Carolina from New Jersey. It was a lot of hard work and a lot of paperwork, but we have settled in nicely. Thank you for your patience while we were in transition.</div>
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In August, Wall Street Journal journalist interviewed Rachel Brummert and the article was published on August 3rd. Idelle did a fantastic job on the article and we thank her for her for her hard work. <a href="https://www.washingtonpost.com/national/health-science/it-pays-to-read-the-warnings-when-you-open-up-a-prescription/2015/08/03/a29e11b4-d70e-11e4-b3f2-607bd612aeac_story.html?tid=hpModule_9d3add6c-8a79-11e2-98d9-3012c1cd8d1e">https://www.washingtonpost.com/national/health-science/it-pays-to-read-the-warnings-when-you-open-up-a-prescription/2015/08/03/a29e11b4-d70e-11e4-b3f2-607bd612aeac_story.html?tid=hpModule_9d3add6c-8a79-11e2-98d9-3012c1cd8d1e</a><br />
<br />
Tulsa World <a href="http://www.tulsaworld.com/opinion/idelle-davidson-the-risky-business-of-taking-antibiotics/article_bcce562a-bd78-5d92-b156-6926115be61c.html?TNNoMobile">http://www.tulsaworld.com/opinion/idelle-davidson-the-risky-business-of-taking-antibiotics/article_bcce562a-bd78-5d92-b156-6926115be61c.html?TNNoMobile</a><br />
and <a href="http://www.courant.com/consumer/hc-ls-antibiotics-drug-reaction-20150821-story.html">http://www.courant.com/consumer/hc-ls-antibiotics-drug-reaction-20150821-story.html </a>picked up the story.<br />
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At the end of August, QVF produced a video called Shattered Lives:
Destroyed by Fluoroquinolone Toxicity. It was widely shared and we
raised a lot of awareness. Thank you to all who shared it and
participated in it. <br />
<br />
Facebook: <a href="https://www.facebook.com/video.php?v=956683854350489&set=vb.207825862569629&type=3&theater">https://www.facebook.com/video.php?v=956683854350489&set=vb.207825862569629&type=3&theater</a><br />
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YouTube: <a href="https://www.youtube.com/watch?v=DOEDyfvYo-o">https://www.youtube.com/watch?v=DOEDyfvYo-o</a><br />
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We also got an update about the fluoroquinolone lawsuits that were filed by Baron & Budd law firm on behalf of clients who suffer with peripheral neuropathy. The cases were consolidated in Minnesota, which is good news. </div>
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In September, Chris Butler joined our team and was elected to the Board of Directors in September 2015 and serves as Vice President. He works in Federal Employment Law, utilizing his skills in effective workplace communication, and problem resolution. Mr. Butler holds a B.S. in Human Resource Management from Friends University and an Associates Degree in Applied Science in Business. He retired from the United States Army in 2001 and has held many positions in his career including Instructor, Field Artillery Cannon Crew Chief, Survey Party Chief, leadership development training programs and Human Resources. He also currently serves as Ambassador for the Kansas City area. </div>
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Also in September, Steven Brill wrote a scathing 15 part series about
Johnson & Johnson, “America's Most Admired Lawbreaker”. We are
eternally grateful for his comprehensive coverage. <a href="http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/">http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/</a></div>
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Unfortunately, we did get some disappointing news. QVF had been trying to work with a mayor and a governor to bring awareness about fluoroquinolone toxicity and to have it recognized on a local and state level. After submitting the necessary applications, paperwork, and documentation, and waiting several months for a response, we received responses and unfortunately they have both rejected our applications.</div>
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We did our best and we will continue to approach other officials. The mayor declined on the grounds of this being too "controversial". The governor did not specify a reason.We obviously hoped for a different outcome, but this will not deter us from trying again elsewhere. As we like to say here at QVF "If someone tells you no, you are asking the wrong person". This illustrates an important point of what we are up against. It is difficult to get doctors to listen and it is difficult to get the attention on fluoroquinolone toxicity that it deserves. We vow to keep trying and we will keep you updated on our progress.</div>
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In October, we spoke to Dr. Noble from the University of Rochester for an update on his research. Dr. Noble ran into a bit of an issue in regards to the preclinical phase of the research study. However, he has assured us that this issue is of little importance. The more important thing we can share is that he has identified a team that has a mouse model predisposed to certain factors in their health in order to better represent the spectrum of problems that have been caused by FQ exposure that will help him push forward in the study. This avenue looks very promising and we look forward to seeing where this goes. As always we appreciate his hard work.</div>
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On November 4, Executive director Rachel Brummert and author Josh Rivedal were interviewed about their upcoming book The i'Mpossible Project: Reengaging with Life, Creating a New You, due out January 13, 2016. Ms. Brummert was also interviewed about the FDA hearing at which she was testifying the following day.<a href="http://wric.com/2015/11/04/fda-to-hear-patient-complaints-about-commonly-prescribed-antibiotics/"> http://wric.com/2015/11/04/fda-to-hear-patient-complaints-about-commonly-prescribed-antibiotics/</a></div>
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Ms. Brummert and QVF Ambassador Jonathan Furman presented a plaque to
reporter Kerri O'Brien for all of her coverage on fluoroquinolones since
April. Ms. O'Brien has run several stories on fluoroquinolones and she
also covered the FDA hearing which was happening the next day. Thank you
to two very generous QVF staff who paid for Ms. O'Brien's plaque out of
their own pockets. </div>
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Rachel Brummert and Jonathan Furman joined 33 others, many of whom are victims of fluoroquinolones, and testified at the FDA at the Antimicrobial Drugs Advisory Committee (ADMAC) and Drug Safety and Risk Management Advisory Committee. The panel discussed the risks/benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of sinus infections, urinary tract infections (UTIs) and bronchitis. The panel reviewed evidence and listened to testimony from victims during the Open Public Hearing portion of the meeting. </div>
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Thank you to everyone who traveled to Maryland to speak and those who came to support the speakers. Seeing everyone come together to call on the FDA to take action on fluoroquinolones was a wonderful experience.</div>
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To hear everyone's testimony, click here: <a href="https://collaboration.fda.gov/p7q9g54ygww/?launcher=false&fcsContent=true&pbMode=normal">https://collaboration.fda.gov/p7q9g54ygww/?launcher=false&fcsContent=true&pbMode=normal</a></div>
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Ms Brummert wrote a guest blog about testifying at the FDA. <a href="https://baronandbudd.com/protecting-whats-right/2015/11/fda-takes-notice-of-fluoroquinolone-associated-disability/?utm_source=facebook&utm_medium=social&utm_content=Oktopost-facebook-profile&utm_campaign=Oktopost-FLQ">https://baronandbudd.com/protecting-whats-right/2015/11/fda-takes-notice-of-fluoroquinolone-associated-disability/?utm_source=facebook&utm_medium=social&utm_content=Oktopost-facebook-profile&utm_campaign=Oktopost-FLQ</a><br />
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The twenty-one member FDA panel voted 21-0 for a label revision on
sinusitis, 20-1 for UTIs, and 18-2 with one abstention for bronchitis.<a href="http://news.sys-con.com/node/3553775"> http://news.sys-con.com/node/3553775.</a><br />
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We await a decision from the FDA about when/if they will implement the panel's recommendations.</div>
Also in November, QVF produces a video called “But You Don't Look Sick”, putting in the spotlight that fluoroquinolone toxicity is an invisible illness. <a href="https://www.youtube.com/watch?v=bof4-Uyt7ME">https://www.youtube.com/watch?v=bof4-Uyt7ME</a><br />
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Consumer Reports mentions fluoroquinolones in their Consumer Reports Health Letter. QVF has been talking with them and we look forward to more projects. </div>
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Journalist Yee-Liu Williams wrote an article about the November FDA
hearing and quoted executive director Rachel Brummert in her article. <a href="https://medium.com/the-intrepid-fascinator/fluoroquinolones-an-advisory-fda-panel-urge-drug-companies-for-clearer-and-prominent-label-1c6a2980fe5f#.euxpmg3mq">https://medium.com/the-intrepid-fascinator/fluoroquinolones-an-advisory-fda-panel-urge-drug-companies-for-clearer-and-prominent-label-1c6a2980fe5f#.euxpmg3mq</a></div>
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In December, we had the sad duty to inform everyone that Dr. David
Flockhart from the University of Indiana passed away. Dr. Flockhart had
treated patients with FQ Toxicity for years and was a leading doctor in
this field. He will be missed and our thoughts and prayers are with his
family during this difficult time.<a href="http://www.legacy.com/obituaries/indystar/obituary.aspx?n=david-a-flockhart&pid=176686429">http://www.legacy.com/obituaries/indystar/obituary.aspx?n=david-a-flockhart&pid=176686429</a></div>
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QVF also added attorney Scott Harford to our website on the Fluoroquinolone Lawsuits page. <a href="http://www.saferpills.org/resources/fluoroquinolone-lawsuits/">http://www.saferpills.org/resources/fluoroquinolone-lawsuits/</a></div>
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Mr. Harford has been representing individuals suffering from Avelox-induced structural eye injuries since 2013. <a href="http://harford-law.com/aveloxocular-injuries/">http://harford-law.com/aveloxocular-injuries/ </a></div>
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His law firm is accepting cases from all 50 states. If you have structural eye injuries as a result of Avelox, please contact Mr. Harford for a free case review. </div>
<div class="_2cuy _3dgx _2vxa">
<span class="skype_c2c_container notranslate" data-isfreecall="false" data-ismobile="false" data-isrtl="false" data-numbertocall="+12123908983" data-numbertype="paid" dir="ltr" id="skype_c2c_container" tabindex="-1"><span class="skype_c2c_highlighting_inactive_common" dir="ltr"><span class="skype_c2c_textarea_span" id="non_free_num_ui"><img class="skype_c2c_logo_img" height="0" src="resource://skype_ff_extension-at-jetpack/skype_ff_extension/data/call_skype_logo.png" width="0" /><span class="skype_c2c_text_span">212-390-8983</span><span class="skype_c2c_free_text_span"></span></span></span></span></div>
<div class="_2cuy _3dgx _2vxa">
299 Broadway, Suite 1310</div>
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New York, New York 10007</div>
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<a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fharford-law.com%2F&h=jAQGiLts4&s=1" rel="nofollow" target="_blank">http://harford-law.com/</a></div>
<div class="_2cuy _3dgx _2vxa">
scott.harford@harford-law.com</div>
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<div class="_2cuy _3dgx _2vxa">
As always, the Quinolone Vigilance Foundation receives no compensation of any kind from the law firms listed on our website. There are several other attorneys who are taking cases who are not listed on our site. To be listed on our site, we must be able to interview them extensively, review their CVs, and be able to verify with the American Bar Association that they are attorneys in good standing. All three criteria are required to be listed on the QVF website. Whether listed on our site or not, it is important that you are comfortable with any attorney you choose and we encourage victims to use who they are comfortable with. </div>
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Also in December, QVF received the disappointing news that the FDA decision regarding the generic loophole was delayed a second time (we started talking about this earlier). The hearing was on March 27, 2015 and a decision was supposed to be reached in September 2015. The decision was then delayed until February 2016. In the FDA's agenda, released in November, the decision was again delayed and now it is scheduled for July 2016. QVF issued a press release urging the FDA to stop with the delays and put patient safety first, echoing outrage by Public Citizen. <a href="http://finance.yahoo.com/news/fda-delay-safety-rule-leaves-140200312.html">http://finance.yahoo.com/news/fda-delay-safety-rule-leaves-140200312.html</a> </div>
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QVF also weighed in on the 21st Century Cures Act, a bill that was
passed in the House of Representatives, and now the Senate is working on
a similar one. Unfortunately, the 21st Century Cures Act has several
provisions that are especially worrisome and would weaken consumer
safety, leaving patients exposed to potentially unsafe medications. QVF
contacted North Carolina Senators Richard Burr and Thom Tillis urging
them to amend the bill before it becomes law. If the law passes “As Is”
consumer protection will take an even deeper hit than it already is. We
urge everyone to join us in urging the Senate to make necessary changes
to the bill before it is too late. <a href="https://www.facebook.com/notes/quinolone-vigilance-foundation/call-to-action-21st-century-cures-act/1056122027740004">https://www.facebook.com/notes/quinolone-vigilance-foundation/call-to-action-21st-century-cures-act/1056122027740004</a></div>
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<div class="_2cuy _3dgx _2vxa">
Many news stories ran this year. It's been continuous coverage since
November of last year and we are very proud of everyone who reached out
to the media and told their stories. Fluoroquinolone toxicity reached a
new level of advocacy this year and we could not be more pleased of
everyone's advocacy efforts. Keep up the good work! <a href="https://www.facebook.com/notes/quinolone-vigilance-foundation/qvf-fqs-in-the-media/866857179999824">https://www.facebook.com/notes/quinolone-vigilance-foundation/qvf-fqs-in-the-media/866857179999824 </a></div>
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On December 16, we were asked by the National Center for Health Research to join the Patient, Consumer, and Public Health Coalition. We are truly honored and we thank NCHR for recognizing our work.</div>
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Sadly, we had to postpone our annual auction twice in November due to staff medical emergencies and deaths in our families. We don't yet know when it will be rescheduled but we are doing our best. In the meantime, please support QVF through our online store <a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fwww.cafepress.com%2Fquinvigil&h=KAQHaJFVj&s=1" rel="nofollow" target="_blank">www.cafepress.com/quinvigil</a>, KonectIDY <a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fkonectidy.com%2Fcharity%2Fquinolone-vigilance-foundation%2F&h=YAQGbheE1&s=1" rel="nofollow" target="_blank">http://konectidy.com/charity/quinol...</a>, via PayPal using donations@saferpills.org or a check to Quinolone Vigilance Foundation, 9817 Stephen Thompson Lane, Charlotte, NC 28213. Your donation will help us continue our work in advocacy, educating doctors, and funding upcoming research. QVF is a 501(c)(3) organization and donations are tax deductible. QVF staff are all volunteers and we receive no compensation of any kind. We do not have sponsors and we rely on private donations. Thank you to everyone who donated to us in 2015. We take our responsibility to the fluoroquinolone community very seriously and we got a lot done thanks to your support.</div>
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</div>
<div class="_2cuy _3dgx _2vxa">
QVF has accomplished quite a bit in 2015, and we are looking forward to another productive year with your support.</div>
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</div>
<div class="_2cuy _3dgx _2vxa">
Without all of you, our Board of Directors, volunteer staff, and Ambassadors, we would not be able to do what we do. </div>
<div class="_2cuy _3dgx _2vxa">
</div>
<div class="_2cuy _3dgx _2vxa">
Rachel Brummert, Executive Director</div>
<div class="_2cuy _3dgx _2vxa">
Chris Butler, Vice President</div>
<div class="_2cuy _3dgx _2vxa">
Donna Schutz, Assistant Director</div>
<div class="_2cuy _3dgx _2vxa">
Leslie Day, Assistant Director and Secretary</div>
<div class="_2cuy _3dgx _2vxa">
Christina Manthos-Sorrell, Treasurer</div>
<div class="_2cuy _3dgx _2vxa">
Victoria Chiovare, Fundraising Director</div>
<div class="_2cuy _3dgx _2vxa">
Jenny Frank, Public Relations Director</div>
</div>
</div>
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Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-81921570794677827282015-12-19T08:26:00.001-08:002015-12-19T08:26:14.268-08:00Quinolone Vigilance Foundation: Who We Are, What We Do video<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEimIyZzCL64JtwGJYGaOQUsB7iMbes9mRoVuhA-ldFzS71MklJ1DxCoGpj8DKx095GluWGWqvlfvXfLzkaypsLrMQ46zx1fig4_7-xD6Psi6R504fh1bW7p6aJBmw_8qgc-rwMI49pVhv0/s1600/letterhead.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="117" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEimIyZzCL64JtwGJYGaOQUsB7iMbes9mRoVuhA-ldFzS71MklJ1DxCoGpj8DKx095GluWGWqvlfvXfLzkaypsLrMQ46zx1fig4_7-xD6Psi6R504fh1bW7p6aJBmw_8qgc-rwMI49pVhv0/s320/letterhead.jpg" width="320" /></a></div>
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Our latest video about who we are and what we do.<br />
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<iframe width="320" height="266" class="YOUTUBE-iframe-video" data-thumbnail-src="https://i.ytimg.com/vi/BpFLNFNmxzo/0.jpg" src="https://www.youtube.com/embed/BpFLNFNmxzo?feature=player_embedded" frameborder="0" allowfullscreen></iframe></div>
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Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-22106760363306408902015-12-07T13:33:00.003-08:002016-02-05T17:28:48.476-08:00Call to Action: 21st Century Cures Act<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjg407qwbhTp5DwYh873bTSrV2ibLKkT_VYpKh_FOZbZCkbY6t-LsYXw0JAeBUzq87kDhSssZ3Iq42DvVx9sPvYzHjnThsSumKsy-UfKLjfADxmitbb0yWAGnAgVdCp8EUYDHLkrNPSvTM/s1600/letterhead.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="117" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjg407qwbhTp5DwYh873bTSrV2ibLKkT_VYpKh_FOZbZCkbY6t-LsYXw0JAeBUzq87kDhSssZ3Iq42DvVx9sPvYzHjnThsSumKsy-UfKLjfADxmitbb0yWAGnAgVdCp8EUYDHLkrNPSvTM/s320/letterhead.jpg" width="320" /></a></div>
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<div class="_2cuy _3dgx">
Recently, The House Energy and Commerce Committee of the U.S House of Representatives unanimously passed the 21st Century Cures Act in a 51-0 vote, essentially putting pharmaceutical companies before patient safety. The U.S Senate is working on similar legislation.</div>
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Unfortunately, the 21st Century Cures Act has several provisions that are especially worrisome and would weaken consumer safety, leaving patients exposed to potentially unsafe medications.</div>
<div class="_2cuy _3dgx">
The bill weakens an already flawed system and would lower the standards by which the FDA approves antibiotics, putting patients at risk and giving companies big shortcuts when it comes to clinical testing of high-risk antibiotics like fluoroquinolones.<br />
</div>
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If enacted into law, the 21st Century Cures Act would allow for more fast-tracking of medications, and eliminate Phase III clinical trials as a requirement for drug approval. Phase III is when the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Eliminating this important phase would mean that the FDA would be able to approve drugs based on smaller phase II studies alone. Many medications, especially fluoroquinolone antibiotics, come with adverse reactions that are not known until long after the drug is approved. Bypassing critical safety protocols by fast-tracking medications means that more patients will not find out how dangerous they are until years later. Post-market surveillance relies on human subjects to provide the data to prove safety and effectiveness of a medication after it has been approved by the FDA. Alarmingly, there are no provisions in the 21st Century Cures Act to fund the FDA's examination of post market data.<br />
</div>
<div class="_2cuy _3dgx">
</div>
<div class="_2cuy _3dgx">
The current version of the 21st Century Cures Act would allow consideration of drug approvals based on case studies and medical journals alone, rather than making considerations on evidence-based science and data. The legislation seems backward rather than forward-looking, contrary to what its name suggests. In an era of big data and high tech breakthroughs in medicine, institutional acceptance of non-scientific approaches sends the wrong message about the FDA's role in protecting the public. It risks losing the respect and support of the scientific community and the public. In effect, the FDA would give no more assurance than a patient's favorite health magazine which, however reputable, is not based on controlled experimental evidence, but is a collection of opinions from conflicting sources with potentially varying agendas. Patients would surely wonder whether their tax dollars are being spent wisely.<br />
</div>
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</div>
<div class="_2cuy _3dgx">
Additionally, the 21st Century Cures Act will encourage the production of new antibiotics, regardless of their safety profile or mechanism of action. The legislation includes incentives to prescribe newly developed antibiotics. Hospitals would receive a bonus for using new antibiotics, that would lead to more over-use and antibiotic resistance, which undermines one of the issues the legislation is supposed to address. Antibiotic resistance is a rapidly growing epidemic. The answer to antibiotic resistance is not the development of new antibiotics. It is the over-prescribing and over-use of existing antibiotics that caused it in the first place. Instead of using fluoroquinolone antibiotics as a last resort for life-threatening infections such as anthrax, doctors are prescribing them for routine, simple infections for which there are safer alternatives. Encouraging the production of new, more powerful antibiotics will only compound the problem, and disable and kill people more than fluoroquinolones already are. But if the 21st Century Cures Act passes, removing regulatory and procedural requirements from the drug approval process is exactly what will be allowed to happen. Instead of protecting patients from already dangerous antibiotics, this will only encourage even more dangerous antibiotics to enter the market and put more patients at risk.<br />
</div>
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</div>
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A preventable problem is a fixable problem and we can fix the flaws so patients are protected with improved treatments that are safe and effective without compromising patient safety.</div>
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</div>
<div class="_2cuy _3dgx">
The bill has already passed in the House of Representatives, but it has not in the Senate. It is up to us to voice our concerns about this legislation and let our elected officials know that patient safety should be of paramount importance and that the loopholes in this legislation must be closed. There is still time to amend legislation before more lives are destroyed.<br />
</div>
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</div>
<div class="_2cuy _3dgx">
Contact the primary authors of the bill- Congressman Fred Upton and Congresswoman Diana DeGette- and let them know how you feel about this legislation and how it will lead to more preventable harm. Also contact your Senators. The Quinolone Vigilance Foundation has already sent letters, which you may use as an example, or write your own. Please join us and demand that the Senate puts patients first. It is not too late to get this bill amended by the Senate before it becomes law.<br />
</div>
<div class="_2cuy _3dgx">
</div>
<div class="_2cuy _3dgx">
<a href="http://www.contactingthecongress.org/cgi-bin/newmemberbio.cgi?lang&member=MI06&site=ctc2011">Fred Upton</a></div>
<div class="_2cuy _3dgx">
<a href="https://degette.house.gov/contact/send-me-an-email/email-me">Diana DeGette</a></div>
<div class="_2cuy _3dgx">
<a href="http://www.senate.gov/general/contact_information/senators_cfm.cfm#">Contact your Senator</a><br />
</div>
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<div class="_2cuy _3dgx">
Letter from the Quinolone Vigilance Foundation to North Carolina United States Senators Richard Burr and Thom Tillis:</div>
<div class="_2cuy _3dgx">
<br /></div>
<div class="_2cuy _3dgx">
Dear Senators Burr and Tillis,<br />
</div>
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</div>
<div class="_2cuy _3dgx">
I am writing to express my concern over a bill recently passed by the U.S. House of Representatives that would lower the Food and Drug Administration's standards for approving drugs and medical devices. As you consider legislation intended to promote medical innovation, I strongly urge you to reject provisions that would undermine the FDA's ability to make sure treatments are safe and effective.<br />
</div>
<div class="_2cuy _3dgx">
</div>
<div class="_2cuy _3dgx">
In 2006, I became disabled after suffering severe adverse reactions to the fluoroquinolone antibiotic Levaquin. To date, I have ruptured ten (10) tendons, and endured over a dozen other adverse reactions including a neurodegenerative disorder, from which I will never recover. </div>
<div class="_2cuy _3dgx">
</div>
<div class="_2cuy _3dgx">
If enacted into law, the 21st Century Cures Act would allow for more fast-tracking of medications, and eliminate Phase III clinical trials as a requirement for drug approval. Many medications, especially fluoroquinolone antibiotics, come with adverse reactions that are not known until long after the drug is approved. Bypassing critical safety protocols by fast-tracking medications means that more patients will not find out how dangerous they are until years later. Post-market surveillance relies on human subjects to provide the data to prove safety and effectiveness of a medication after it has been approved by the FDA. Alarmingly, there are no provisions in the 21st Century Cures Act to fund the FDA's examination of post market data.<br />
</div>
<div class="_2cuy _3dgx">
</div>
<div class="_2cuy _3dgx">
The current version of the 21st Century Cures Act would allow consideration of drug approvals based on case studies and medical journals alone, rather than making considerations on evidence-based science and data. This seems backward rather than forward-looking, contrary to what its name suggests. In an era of big data and high tech breakthroughs in medicine, institutional acceptance of non-scientific approaches sends the wrong message about the FDA's role in protecting the public. In effect, this would give no more assurance than a patient's favorite health magazine which, however reputable, is not based on controlled experimental evidence, but is a collection of opinions from conflicting sources with potentially varying agendas. Patients would surely wonder whether their tax dollars are being spent wisely.<br />
</div>
<div class="_2cuy _3dgx">
</div>
<div class="_2cuy _3dgx">
Additionally, the 21st Century Cures Act will encourage the production of new antibiotics, regardless of their safety profile or mechanism of action and includes incentives to prescribe newly developed antibiotics. That would lead to more over-use and antibiotic resistance, which undermines one of the issues the legislation is supposed to address. Antibiotic resistance is a rapidly growing epidemic. The answer to antibiotic resistance is not the development of new antibiotics. It is the over-prescribing and over-use of existing antibiotics that caused it in the first place. Encouraging the production of new, more powerful antibiotics will only injure, disable, and kill more patients instead of protecting them from already dangerous antibiotics.<br />
</div>
<div class="_2cuy _3dgx">
</div>
<div class="_2cuy _3dgx">
But if the 21st Century Cures Act passes, removing regulatory and procedural requirements from the drug approval process is exactly what will be allowed to happen.<br />
</div>
<div class="_2cuy _3dgx">
</div>
<div class="_2cuy _3dgx">
A preventable problem is a fixable problem and we can fix the flaws so patients are protected with improved treatments that are safe and effective without compromising patient safety.<br />
</div>
<div class="_2cuy _3dgx">
</div>
<div class="_2cuy _3dgx">
The bill has already passed in the House of Representatives, but it has not in the Senate. Going forward, the Senate must amend the serious mistakes made by the House. I strongly urge you to put consumers first in the medical marketplace, and keep treatments safe, effective and affordable.</div>
<div class="_2cuy _3dgx">
</div>
<div class="_2cuy _3dgx">
Please take measures to balance the 21st Century Cures Act to ensure that patient safety and consumer protection are not overlooked and adverse reactions to medications and medical devices are taken into consideration.<br />
</div>
<div class="_2cuy _3dgx">
</div>
<div class="_2cuy _3dgx">
Thank you for your time and consideration.</div>
<div class="_2cuy _3dgx">
<br /></div>
<div class="_2cuy _3dgx">
Rachel Brummert</div>
<div class="_2cuy _3dgx">
Executive Director</div>
<div class="_2cuy _3dgx">
Quinolone Vigilance Foundation</div>
<div class="_2cuy _3dgx">
<a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fwww.SaferPills.org%2F&h=6AQHdhIZ7&s=1" rel="nofollow" target="_blank">www.SaferPills.org</a></div>
<div class="_2cuy _3dgx">
Charlotte, NC</div>
<div class="_2cuy _3dgx">
<br /></div>
</div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjsoeD07n3cVb0_Vsf7e9Ml_7LWvxQC-Zp8elktGVQBarBniFNjyREu0415uadoaFImI7tGIYHV7J7LiQw9nIDkxA9gRSoKi5PHrYBJaIOL0PtKBY1A7RPnDPyfCmmp6oEWYifbce2TlSQ/s1600/QVF_21CenturyCuresAct_congressional_letter_Burr1.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjsoeD07n3cVb0_Vsf7e9Ml_7LWvxQC-Zp8elktGVQBarBniFNjyREu0415uadoaFImI7tGIYHV7J7LiQw9nIDkxA9gRSoKi5PHrYBJaIOL0PtKBY1A7RPnDPyfCmmp6oEWYifbce2TlSQ/s320/QVF_21CenturyCuresAct_congressional_letter_Burr1.jpg" width="232" /></a></div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0gGTOOEfysPN-dD2s6LfowrQNeeDotorfmAF5yeuxentcXyrNUvQy7WrWHvJOdeyYRB-fzxs1Log4lHctylKu76q7lWGMVZ00lLchHvpkZmI9jdo3qnxgnD3IH9a7t7p6eRyC_3e5eYI/s1600/QVF_21CenturyCuresAct_congressional_letter_Tillis2.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0gGTOOEfysPN-dD2s6LfowrQNeeDotorfmAF5yeuxentcXyrNUvQy7WrWHvJOdeyYRB-fzxs1Log4lHctylKu76q7lWGMVZ00lLchHvpkZmI9jdo3qnxgnD3IH9a7t7p6eRyC_3e5eYI/s320/QVF_21CenturyCuresAct_congressional_letter_Tillis2.jpg" width="232" /></a></div>
<div class="_2cuy _3dgx">
Response from Senator Thom Tillis on December 15, 2015<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgVrSsCzcfDEDrUKpiWXESr98OXWPQWvdVtUGIq3CzlX0T6QRnMSXcv8ezE4TInL_-4yPMemZvsBKrd3PFUHT_oSC2-qLjq3k9V3GCzT9xsbPJp2cNlKJ3lyxRCdfU4R1i1wV5GUexMeCo/s1600/QVF_Tillis_response.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="297" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgVrSsCzcfDEDrUKpiWXESr98OXWPQWvdVtUGIq3CzlX0T6QRnMSXcv8ezE4TInL_-4yPMemZvsBKrd3PFUHT_oSC2-qLjq3k9V3GCzT9xsbPJp2cNlKJ3lyxRCdfU4R1i1wV5GUexMeCo/s320/QVF_Tillis_response.jpg" width="320" /></a></div>
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Response from Senator Richard Burr:<br />
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Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-74221571785003294642015-12-07T13:26:00.004-08:002015-12-07T13:26:36.619-08:00Press Release: FDA Delay in Safety Rule Leaves Patients at Risk<br />
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<br /><h1 class="headline" id="yui_3_18_1_1_1449523404980_945">
<span style="font-size: x-small;">FDA Delay in Safety Rule Leaves Patients at Risk</span></h1>
<h1 class="headline" id="yui_3_18_1_1_1449523404980_945">
<span style="font-size: x-small;">Completion Date for Generic Labeling delayed until July 2016</span></h1>
<div id="yui_3_18_1_1_1449523404980_2355">
CHARLOTTE, N.C., Dec. 7, 2015
/PRNewswire-iReach/ -- The Food and Drug Administration (FDA) has
postponed for a second time a decision on whether to close an important
drug safety loophole, leaving millions of patients who rely on generic
medications at serious risk.</div>
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Currently,
patients who are harmed by a generic drug cannot sue the manufacturer.
Even more distressing, manufacturers of generic drugs are not required
to update the patient warning labels like manufacturers of brand name
drugs are.</div>
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The FDA has not
yet finalized a proposed labeling rule and has several times delayed its
expected completion date. Originally scheduled for September, it was
delayed until February 2016. However, in its regulatory agenda, released
in November, the FDA has now pushed back the date even further to July
2016.</div>
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The FDA's proposed rule
is in response to a Citizen Petition filed by consumer safety advocacy
group Public Citizen. On March 27, 2015 the FDA held a Supplemental
Applications Proposing Labeling Changes for Approved Drugs and
Biological Products hearing in White Oak, Maryland.</div>
<div id="yui_3_18_1_1_1449523404980_2363">
Rachel
Brummert, executive director of the Quinolone Vigilance Foundation,
testified on behalf of herself and other patients who took a generic
fluoroquinolone antibiotic such as levofloxacin, ciprofloxacin,
moxifloxacin and others, and were disabled by them. She urged the FDA to
take action and close the generic drug loophole.</div>
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"Patients who
are hurt by generic drugs should have the same rights as those who are
injured by brand name versions of the same medications. Lives could be
saved and injuries prevented if all prescription medications carried
up-to-date and adequate warning labels. Finalizing the proposed rule by
the FDA will promote safety by holding generic drug manufacturers
accountable and would speed the dissemination of safety information to
doctors and patients. A delay in finalizing the proposed rule will only
lead to more patients being hurt", says Ms. Brummert.<br />
<br />
Unfortunately,
the delay has happened a second time, leaving Brummert gravely
concerned. "More patients have been hurt, and will continue to be hurt,
by generic medications due to this delay".<br />
<div id="yui_3_18_1_1_1449523404980_2365">
The
generic drug loophole has gained the attention of United States Senator
Al Franken, who asked FDA Commissioner nominee Dr. Robert Califf during
a recent Senate hearing about the current plan to finalize the labeling
rule.</div>
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<div id="yui_3_18_1_1_1449523404980_2367">
Rachel Brummert, and
other victims who were harmed by generic medications, are grateful that
others are taking notice of this important proposed rule. "Generic drugs
account for more than 80 percent of prescriptions in the United States,
and under current guidelines, patients are at serious risk. The
Quinolone Vigilance Foundation urges the FDA to close the generic
loophole promptly and to end the delays to ensure that patients have
access to updated safety information in a timely manner", affirms
Brummert.</div>
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<div class="c1" id="yui_3_18_1_1_1449523404980_2375">
<b>About The Quinolone Vigilance Foundation</b></div>
<div class="c1" id="yui_3_18_1_1_1449523404980_2375">
<br /></div>
<div id="yui_3_18_1_1_1449523404980_2373">
The Quinolone Vigilance Foundation (QVF)--<a data-rapid_p="8" href="http://www.saferpills.org/" id="yui_3_18_1_1_1449523404980_2377" rel="nofollow" target="_blank">www.SaferPills.org</a>-
is a non-profit, charitable foundation that helps raise awareness about
fluoroquinolone antibiotics and their dangers among patients and
medical professionals, and funds research on fluoroquinolone toxicity.</div>
<div id="yui_3_18_1_1_1449523404980_2371">
<b>Media Contact:</b> Rachel Brummert, Quinolone Vigilance Foundation, <span class="skype_c2c_container notranslate" data-isfreecall="false" data-ismobile="false" data-isrtl="false" data-numbertocall="+16095759839" data-numbertype="paid" dir="ltr" id="skype_c2c_container" tabindex="-1"><span class="skype_c2c_highlighting_inactive_common" dir="ltr"><span class="skype_c2c_textarea_span" id="non_free_num_ui"><img class="skype_c2c_logo_img" height="0" src="resource://skype_ff_extension-at-jetpack/skype_ff_extension/data/call_skype_logo.png" width="0" /><span class="skype_c2c_text_span">609-575-9839</span><span class="skype_c2c_free_text_span"></span></span></span></span>, <a data-rapid_p="9" href="mailto:rachel@saferpills.org" rel="nofollow">rachel@saferpills.org</a></div>
<h1 class="headline" id="yui_3_18_1_1_1449523404980_945">
<span style="font-size: x-small;"> </span></h1>
Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-32164298571909154722015-11-15T22:39:00.005-08:002015-11-15T22:39:44.500-08:00Press release: New FDA Panel is a Big Win for Victims of Fluoroquinolone Antibiotics<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiAR7XAXzYvIl2APWtHTmZFVQGkisU93QWTAUIfpz_g1S1TZ8KCW_6FaNJBpOWpknP0q0CIdDYq4ylZWmv-elP4fjVaa-9pq_hsuWVCPZSvXdB__lVdXmqN6b_9DE7JuVyR1RoQc3Dzp18/s1600/letterhead.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="117" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiAR7XAXzYvIl2APWtHTmZFVQGkisU93QWTAUIfpz_g1S1TZ8KCW_6FaNJBpOWpknP0q0CIdDYq4ylZWmv-elP4fjVaa-9pq_hsuWVCPZSvXdB__lVdXmqN6b_9DE7JuVyR1RoQc3Dzp18/s320/letterhead.jpg" width="320" /></a></div>
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New FDA Panel is a Big Win for Victims of Fluoroquinolone Antibiotics</h1>
<h2 class="xn-hedline">
Quinolone Vigilance Foundation Applauds the FDA Panel's Recommendation to Limit Fluoroquinolone Use</h2>
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PR Newswire</div>
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<span class="xn-location">CHARLOTTE, N.C.</span>, <span class="xn-chron">Nov. 12, 2015</span>
/PRNewswire-iReach/ -- The Quinolone Vigilance Foundation testified
before an FDA advisory panel last week to help save lives from the
dangerous antibiotics known as fluoroquinolones. The FDA panel on
fluoroquinolones is a big step in helping to keep patients who need
antibiotics safe.<br />
<br />
Photo - <a href="http://photos.prnewswire.com/prnh/20151112/286639" rel="nofollow" target="_blank">http://photos.prnewswire.com/prnh/20151112/286639</a><br />
<br />
In a recent review, the FDA refers to the constellation of adverse
reactions in previously healthy individuals as
"fluoroquinolone-associated disability."<br />
<br />
The FDA advisory panel voted 21-0 for a label revision on sinusitis,
20-1 for UTIs and 18-2 with one abstention for bronchitis. At this time,
the panel cannot recommend language for stronger warnings because that
is up to the FDA to decide. However, the fact that the panel recognized
that the risks outweigh the benefits in fluoroquinolones is a big win
for victims of fluoroquinolones.<br />
<br />
The panel heard powerful testimony from 35 people, including the Quinolone Vigilance Foundation's executive director <span class="xn-person">Rachel Brummert</span> and <span class="xn-location">Virginia</span> ambassador <span class="xn-person">Jonathan Furman</span>.<br />
<br />
In her testimony, <span class="xn-person">Rachel Brummert</span>
stated, "These antibiotics have the power to destroy lives when they are
prescribed for routine infections like sinus infections and UTIs that
don't need their strength. Just as it is irresponsible to squelch a
kitchen fire with the defenses we would mount against a wildfire,
likewise, it is reckless to use a fluoroquinolone antibiotic to squelch a
routine infection. There are safer, effective antibiotics for the
treatment of routine infections in the event that an antibiotic is even
necessary."<br />
<br />
Brummert's testimony comes after she was prescribed the
fluoroquinolone Levaquin for a routine sinus infection in 2006. Weeks
later, her achilles tendon ruptured in a parking lot, the first of ten
tendon ruptures she was to endure during the next nine years, as well as
other severe adverse reactions, some life-threatening.<br />
<br />
According to <span class="xn-person">Rachel Brummert</span>, "A
first-line of defense antibiotic like Amoxicillin would have resolved my
sinus infection, and I would not have been exposed to the relatively
disproportionate risks of known fluoroquinolone-associated injury, which
includes a progressive neurodegenerative disorder, from which I will
never recover."<br />
<br />
The complications associated with Levaquin and other fluoroquinolone
antibiotics like Cipro and Avelox are severe and may be permanent and
life-threatening.<br />
<br />
The FDA's advisory panel hearing, and telling votes, is a necessary
step in the right direction to keep patients safe from unnecessary and
preventable harm and combating antibiotic resistance.<br />
The Quinolone Vigilance Foundation urges the FDA to continue this
necessary work by further regulating fluoroquinolones, strengthening
warnings in clear language, and applying its highest level of scrutiny
and surveillance of fluoroquinolones.<br />
<br />
<b>About The Quinolone Vigilance Foundation </b><br />
The Quinolone Vigilance Foundation (QVF)--<a href="http://www.saferpills.org/" rel="nofollow" target="_blank">www.SaferPills.org</a>-
is a non-profit, charitable foundation that helps raise awareness about
fluoroquinolone antibiotics and their dangers among patients and
medical professionals, and funds research on fluoroquinolone toxicity.<br />
<br />
<b>Media Contact:</b> <span class="xn-person">Rachel Brummert</span>, Quinolone Vigilance Foundation, <a href="mailto:rachel@saferpills.org" rel="nofollow" target="_blank">rachel@saferpills.org</a> <br />
News distributed by PR Newswire iReach: <a href="https://ireach.prnewswire.com/" rel="nofollow" target="_blank">https://ireach.prnewswire.com</a><br />
<br />
SOURCE Quinolone Vigilance Foundation<br />
</div>
Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-11936885597072716622015-11-15T22:36:00.001-08:002015-11-15T22:36:21.155-08:00Guest blog: FDA Takes Notice of “Fluoroquinolone-Associated Disability”<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh1b1Irf9Zc22m-VSpLvshWWtSBcEVauzcDqpb4pJaklpK-70Azrgw4A-Ucrc3epbauCq7SIJBbePyhK03AGXF8FDODrKAc3QZpNvZPba0gZrmA2cHcrkI_ysDqVR3q3hNS_zs-sBBzMpk/s1600/letterhead.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="117" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh1b1Irf9Zc22m-VSpLvshWWtSBcEVauzcDqpb4pJaklpK-70Azrgw4A-Ucrc3epbauCq7SIJBbePyhK03AGXF8FDODrKAc3QZpNvZPba0gZrmA2cHcrkI_ysDqVR3q3hNS_zs-sBBzMpk/s320/letterhead.jpg" width="320" /></a></div>
<br />
<br />
<br />
<br />
<span style="font-size: xx-small;">*Guest blog written for Baron & Budd Law Firm. The original post <a href="https://baronandbudd.com/protecting-whats-right/2015/11/fda-takes-notice-of-fluoroquinolone-associated-disability/?utm_source=facebook&utm_medium=social&utm_content=Oktopost-facebook-profile&utm_campaign=Oktopost-FLQ">can be found here</a>:</span> <br />
<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg9g6FrWju4k595kue2rIAC4f3MAeI7OZqHxnvgyqIG_RVxRcZ3t4B_CRyU4RJkjh9WfWDKH7lwzxx3stso2VOdznrn0WF0M-CF96VSYxtC653ojN68iLgRBj1U4W8CbH0O_iHjH9HSqKQ/s1600/FDA_november_rachel01.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="180" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg9g6FrWju4k595kue2rIAC4f3MAeI7OZqHxnvgyqIG_RVxRcZ3t4B_CRyU4RJkjh9WfWDKH7lwzxx3stso2VOdznrn0WF0M-CF96VSYxtC653ojN68iLgRBj1U4W8CbH0O_iHjH9HSqKQ/s320/FDA_november_rachel01.jpg" width="320" /></a><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg9g6FrWju4k595kue2rIAC4f3MAeI7OZqHxnvgyqIG_RVxRcZ3t4B_CRyU4RJkjh9WfWDKH7lwzxx3stso2VOdznrn0WF0M-CF96VSYxtC653ojN68iLgRBj1U4W8CbH0O_iHjH9HSqKQ/s1600/FDA_november_rachel01.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"> </a></div>
<br />
Sinusitis, bronchitis and urinary tract infections are common infections
that typically send patients to the doctor looking for relief.<br />
<br />
<br />
Millions of prescriptions are written every year for fluoroquinolone antibiotics such as <strong>Avelox</strong> (moxifloxacin), <strong>Cipro</strong> (ciprofloxacin), and <strong>Levaquin</strong>
(levofloxacin) in pill form, IV, and eye and ear drops. As the number
of prescriptions have increased, so have the number of adverse reactions
reported to the FDA. These adverse reactions encompass several body
systems including the peripheral, autonomic, and central nervous
systems, psychiatric, cardiovascular, musculoskeletal systems, and more.<br />
<br />
The FDA is taking notice of this, and in a recent review, the <a href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM467383.pdf" target="_blank">FDA refers to this constellation of symptoms in previously healthy individuals as “fluoroquinolone-associated disability”.</a><br />
<br />
Fluoroquinolones are incredibly powerful antibiotics with the
capability to save lives when used appropriately as a treatment of last
resort for life-threatening bacterial infections like anthrax. But these
antibiotics also have the power to destroy lives when they are
inappropriately prescribed for routine infections like sinus infections,
uncomplicated UTIs, and bronchitis which don’t need their strength.<br />
<br />
That
is exactly what happened to me. I went to my doctor for treatment of a
routine sinus infection and instead I was inappropriately prescribed an
antibiotic that has disabled me.<br />
<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjhqF0EUlLhlLppfuTQVPlxpX4aXYVeFRqgTaiOzLA5okGk2ZAr-fNfhGvm3X-LrlcAwSOXwC_WNplDx1_BqpW5-_hmrPE31jY1YLOE5HkzgwEyHQzJKkErwUVqPsCaU6h2wcZXOOgHw9g/s1600/FDA_november_rachel02.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="180" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjhqF0EUlLhlLppfuTQVPlxpX4aXYVeFRqgTaiOzLA5okGk2ZAr-fNfhGvm3X-LrlcAwSOXwC_WNplDx1_BqpW5-_hmrPE31jY1YLOE5HkzgwEyHQzJKkErwUVqPsCaU6h2wcZXOOgHw9g/s320/FDA_november_rachel02.jpg" width="320" /></a></div>
On
November 5, 2015, I was honored to testify at the FDA Joint Meeting of
the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk
Management Advisory Committee. (You can watch the video from the meeting
<a href="https://collaboration.fda.gov/p7q9g54ygww/?launcher=false&fcsContent=true&pbMode=normal">here</a>.)
The panel discussed the risk/benefit ratio of fluoroquinolone
antibacterial drugs for the treatment of routine infections. I shared my
story of how I was an otherwise healthy individual who was prescribed
Levaquin for a sinus infection in 2006 and became disabled with ten
tendon ruptures, peripheral neuropathy, cardiac problems, and a
progressive neurodegenerative disorder from which I will never recover.
My sinus infection would have resolved had I been prescribed a safer
alternative and I would not have been exposed to the relatively
disproportionate risks of known fluoroquinolone-associated injury.<br />
And
I was not alone. Thirty-four other people testified to their horrific
injuries and disabilities, and some shared their emotional stories of
having lost a loved one due to these dangerous antibiotics. We came
together with the common goal of fighting for vital changes in how
fluoroquinolones are prescribed to help save others from our fate.<br />
<br />
We
were heard and we made a difference. The panel agreed that the risks
outweigh the benefits when fluoroquinolone antibiotics are
inappropriately prescribed for routine infections. This is the first
time that a government agency acknowledged how widespread the damage is.
And that is huge.<br />
The twenty-one member FDA panel voted 21-0 for a
label revision on sinusitis, 20-1 for UTIs, and 18-2 with one
abstention for bronchitis. The panel did not recommend specific warning
language because a decision on that matter would need to be made by the
FDA. However, the FDA often implements panel recommendations and that is
a reason for hope.<br />
<br />
What happened to me, to everyone else who
testified, and to everyone worldwide who could not be there in person
was preventable. It is too late for us but not too late to save others.
The FDA has a duty and a responsibility to protect the public and
promote public health and therefore the FDA must apply its highest level
of scrutiny, regulation and surveillance of fluoroquinolones to achieve
that goal. We urge the FDA to implement the panel recommendations,
strengthen warnings in clear language, and regulate fluoroquinolones so
that they are only used in life threatening infections.<br />
Anything less and more people will get hurt and that is not acceptable.<br />
<br />
For more information about fluoroquinolones and our work at the Quinolone Vigilance Foundation, please visit our website <a href="http://www.saferpills.org/" rel="nofollow" target="_blank">www.SaferPills.org</a>.<br />
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<h4 class="title-heading-left" data-fontsize="13" data-lineheight="27">
About the Author: <a href="https://baronandbudd.com/protecting-whats-right/author/rbrummert/" rel="author" title="Posts by Rachel Brummert">Rachel Brummert</a></h4>
Rachel Brummert is the Executive Director of the Quinolone Vigilance
Foundation- www.saferpills.org. In her position, she guides strategic
planning for the foundation and acts as its spokesperson. As someone who
has been personally impacted by quinolone toxicity, she oversees the
implementation and evaluation of the organization’s programs, and
promotes collaboration with researchers, donors, politicians, community
groups, and others to further the organization’s mission.</div>
</div>
</div>
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The
views expressed herein reflect the opinions of the author and do not
necessarily reflect the views of Baron & Budd, P.C., its affiliates
or its employees.</div>
Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-30167766514772949722015-11-11T20:48:00.000-08:002015-12-23T08:20:52.381-08:00QVF Testifies at FDA Hearing on November 5, 2015<br />
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<a href="https://www.blogger.com/null" name="advenueINTEXT"></a><a href="https://www.blogger.com/null" name="advenueINTEXT1"></a><span style="font-family: "cambria" , serif;"><span style="font-size: small;"><span lang="en">On October 23,2015 the <a href="http://www.saferpills.org/">Quinolone Vigilance Foundation</a> announced that we were<a href="http://www.bizjournals.com/prnewswire/press_releases/2015/10/23/MN36691"> testifying at the FDA</a>, where <span style="font-family: "cambria" , serif;">an unprecedented hearing was taking place to discuss <span style="font-family: "cambria" , serif;">fluoroquinolone antibiotics.</span></span><a href="https://www.blogger.com/null"> </a></span></span></span><br />
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<span style="font-family: "cambria" , serif;"><span style="font-size: small;"><span lang="en">Th<span style="font-family: "cambria" , serif;">e joint</span> <span style="font-family: "cambria" , serif;">meeting of the </span>Antimicrobial Drugs Advisory Committee (ADMAC)
and Drug Safety and Risk Management Advisory Committee<span style="font-family: "cambria" , serif;"> convened on November 5</span> </span></span></span><span style="font-family: "cambria" , serif;">at which </span><span style="font-family: "cambria" , serif;"><span lang="en">the
panel discussed the risks<span style="font-family: "cambria" , serif;">/</span>benefits of the systemic
fluoroquinolone antibacterial drugs for the treatment of sinus
infections, urinary tract infections (UTIs) and bronchiti<span style="font-family: "cambria" , serif;">s. The pa<span style="font-family: "cambria" , serif;">nel reviewed evidence and listened to testimony from victims during the Open Public Hearing portion of the meeting.</span></span></span></span><br />
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<span style="font-family: "cambria" , serif;"><span lang="en"><span style="font-family: "cambria" , serif;">QVF Ambassador Jonathan Furman<span style="font-family: "cambria" , serif;"> <span style="font-family: "cambria" , serif;">and I joined thirty-thr<span style="font-family: "cambria" , serif;">ee other <span style="font-family: "cambria" , serif;">people who ca<span style="font-family: "cambria" , serif;">me to the FDA to share <span style="font-family: "cambria" , serif;">our</span> stories and to urge the FDA to make vital chang<span style="font-family: "cambria" , serif;">es in how fluoroquinolones are prescribed.</span></span></span></span></span></span> </span> </span></span><br />
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<tr><td class="tr-caption" style="text-align: center;">Jonathan Furman and I in front of the FDA</td></tr>
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<tr><td class="tr-caption" style="text-align: center;">QVF Ambassador Jonathan Furman testifying at the FDA- speaker #13</td></tr>
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The speaker testimonies from all 35 speakers are available <a href="https://collaboration.fda.gov/p7q9g54ygww/?launcher=false&fcsContent=true&pbMode=normal">here.</a><br />
The written transcript can be found <a href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM477657.pdf">here</a>. Open Speaker testimony starts on page 211. Jonathan's testimony starts on page 256. Mine starts on page 282. <br />
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<tr><td class="tr-caption" style="text-align: center;">Me testifying at the FDA</td></tr>
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<tr><td class="tr-caption" style="text-align: center;">I was speaker #21</td></tr>
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This was mine: <br />
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<span style="font-family: "georgia" , "times new roman" , serif;"><b>Good afternoon. My name is Rachel Brummert and I am the
Executive Director of the Quinolone Vigilance Foundation. Neither the
foundation, nor I, have any financial ties to this hearing.</b></span><br />
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<span style="font-size: x-small;">Slide one:</span> <br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhs6TCdj-5zyp49DYAdsRkLs724KkgCC6MXng_tEuZfDHpl7wNGxV0QnkETixx6Nw0tp5S5OnlMnV8sPBrygQK-vQo2eaIk8WinNEoMLJX9wh2-COhFWaqeJsktsTxhaK29ue1joF46PQ8/s1600/QVF_FDA_November_slide1.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="180" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhs6TCdj-5zyp49DYAdsRkLs724KkgCC6MXng_tEuZfDHpl7wNGxV0QnkETixx6Nw0tp5S5OnlMnV8sPBrygQK-vQo2eaIk8WinNEoMLJX9wh2-COhFWaqeJsktsTxhaK29ue1joF46PQ8/s320/QVF_FDA_November_slide1.jpg" width="320" /></a></div>
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<span style="font-family: "georgia" , "times new roman" , serif;"><b>Fluoroquinolone antibiotics are incredibly powerful with the
capability to save lives when used as a treatment of last resort for
life-threatening bacterial infections like anthrax. These antibiotics
have equal power to destroy lives when they are prescribed for
routine infections like sinus infections and UTIs that don’t need
their strength. Just as it is irresponsible to squelch a kitchen fire
with the defenses we would mount against a wildfire, likewise, it is
reckless to use a fluoroquinolone antibiotic to squelch a routine
infection. There are safer, effective antibiotics for the treatment
of routine infections in the event that an antibiotic is even
necessary.</b></span><br />
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<span style="font-size: x-small;">Slide two</span><br />
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<span style="font-size: x-small;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhEZOY1p59yND-_PdzY_8MOozZH4NPzcMtnyLQ_9C396e-nlrRGaWjlj7702Yr21YsAjEx2-E-ytcLr8CdSbk94vUmB94U8JOc8-vZdH-tQNpuJOZkIMvEs23nmKLH2-uxjuP2d1CRqXHw/s1600/QVF_FDA_November_slide2.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="184" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhEZOY1p59yND-_PdzY_8MOozZH4NPzcMtnyLQ_9C396e-nlrRGaWjlj7702Yr21YsAjEx2-E-ytcLr8CdSbk94vUmB94U8JOc8-vZdH-tQNpuJOZkIMvEs23nmKLH2-uxjuP2d1CRqXHw/s320/QVF_FDA_November_slide2.jpg" width="320" /></a></span></div>
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<span style="font-family: "georgia" , "times new roman" , serif;"><b>I am living proof that the risks in using a fluoroquinolone to
treat a routine infection far outweighs the benefits. In 2006, I was
prescribed Levaquin for a sinus infection. Within weeks, my achilles
tendon ruptured in a parking lot, the first of ten tendon ruptures
I’ve suffered over nine years.</b></span><br />
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<span style="font-size: x-small;">Slide three</span><br />
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<b><span style="font-family: "georgia" , "times new roman" , serif;">A first-line of defense antibiotic like Amoxicillin, would
have resolved my sinus infection, and I would not have been exposed
to the relatively disproportionate risks of known
fluoroquinolone-associated injury, which includes a progressive
neurodegenerative disorder, from which I will never recover.</span></b><br />
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<b><span style="font-family: "georgia" , "times new roman" , serif;">With just one prescription, a once-healthy wage-earner,
parent, or grandparent – just like you, just like me – can no
longer enjoy a reasonable quality of life and now lives with lifelong
risks for the development of an illness that is life-threatening.</span></b><br />
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<span style="font-size: x-small;">Slide four</span><br />
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<span style="font-size: x-small;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEinIDn3AmQRB5B1VPZlgFL7-B7PBvKTUH_jijUyVsE4k2fJjn_EMthbuPMyfmU-jCpnxJUnp9iiTxXzn98SntGjEJVr7Gnz5sTfoeHvQN8xy93mJ2a9nfzozt4clQvIbtshtVnKXomT6bs/s1600/QVF_FDA_November_slide4.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="181" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEinIDn3AmQRB5B1VPZlgFL7-B7PBvKTUH_jijUyVsE4k2fJjn_EMthbuPMyfmU-jCpnxJUnp9iiTxXzn98SntGjEJVr7Gnz5sTfoeHvQN8xy93mJ2a9nfzozt4clQvIbtshtVnKXomT6bs/s320/QVF_FDA_November_slide4.jpg" width="320" /></a></span></div>
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<span style="font-family: "georgia" , "times new roman" , serif;"><b>What can the FDA do to protect patients from profound,
preventable harm? A preventable problem is a fixable problem. The FDA
is responsible for protecting and promoting public health through the
regulation and supervision of a wide variety of consumer products
including prescription medications. Fluoroquinolone antibiotics are
causing widespread disability and their overuse is also a
contributing factor in the antibiotic resistance epidemic. Antibiotic
resistance is such an important issue that there is a White House
objective to do something about it. If fluoroquinolones are being
prescribed for routine infections which don’t need their strength
and they are disabling otherwise healthy patients, and their overuse
is leading to an international epidemic, the answer is clear: The FDA
must apply its highest level of scrutiny, regulation and surveillance
of fluoroquinolones to achieve this shared goal.</b></span><br />
<span style="font-family: "georgia" , "times new roman" , serif;"><b><br /></b></span>
<span style="font-family: "georgia" , "times new roman" , serif;"><b>Thank you for your time and consideration and for holding this
very important meeting.</b></span><br />
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<span style="font-family: "georgia" , "times new roman" , serif;">Thirty-five people were compelled to speak at the FDA. Victims, who through enormous pain and disability, traveled so they could look the panel in the eye and tell their emotional, gut-wrenching stories of what fluoroquinolone antibiotics did to them. Not only did speakers speak for themselves, they also spoke for the untold number of victims who could not attend. There were doctors and other experts who conveyed the seriousness of the damage. Still others traveled far and wide to attend the hearing in the audience to support the speakers and to show that there is a strength in numbers and the panel needed to be put on notice that these antibiotics--approved by the FDA without proper testing--are causing injury, disability, and death, and that is not okay. The panel needed to know that unless restrictions are put on these powerful drugs, more people will suffer, more people will lose everything, and more people will die.</span><br />
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<span style="font-family: "georgia" , "times new roman" , serif;">Thirty-five people that day, through their pain and suffering, made a difference. Thousands of people who worked tirelessly through the years made a difference. We all made a difference because we came together and were there to save lives so that what happened to us, doesn't happen to anyone else.</span><br />
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<span style="font-family: "georgia" , "times new roman" , serif;">The advisory panel heard us. The 21 member panel voted 21-0 for a label revision on sinusitis, 20-1 for UTIs, and 18-2 with one abstention for bronchitis. </span><br />
<span style="font-family: "georgia" , "times new roman" , serif;"><br /></span>
<span style="font-family: "georgia" , "times new roman" , serif;">The panel did not recommend specific warning language because only the FDA has the power to do so, and the FDA is not required to follow advisory panel recommendations. But the good news is that the FDA often does follow advisory panel recommendations, and that is reason to hope.</span><br />
<span style="font-family: "georgia" , "times new roman" , serif;"><br /></span>
<span style="font-family: "georgia" , "times new roman" , serif;">Thank you to everyone who attended the hearing, who testified, who supported the speakers, who spoke to the media...everyone. Thank you for all you did at the hearing and in your own communities to raise awareness. It all makes a huge difference.</span><br />
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Rachel Brummert<br />
Executive Director<br />
Quinolone Vigilance Foundation<br />
www.SaferPills.orgAnonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-71464154155544033352015-11-09T20:04:00.000-08:002015-11-11T11:24:19.193-08:00QVF honors WRIC reporter Kerri O'Brien<div class="separator" style="clear: both; text-align: center;">
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The <a href="http://www.saferpills.org/">Quinolone Vigilance Foundation</a> honors WRIC-TV reporter Kerri O'Brien for her continuing coverage on the dangers of fluoroquinolone antibiotics.<br />
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Ms. O'Brien began covering fluoroquinolones in March 2015 when QVF Ambassador Jonathan Furman reached out to her. She interviewed Mr. Furman and QVF Executive Director Rachel Brummert for a story which aired on April 23.<br />
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<span style="font-size: large;"><a href="http://wric.com/2015/04/21/8news-investigates-could-this-antibiotic-permanently-damage-your-health/">You can watch the story here.</a></span><br />
<span style="font-size: x-small;">The first video is the short verson; the second video is the long version.</span><br />
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Ms. O'Brien is so passionate about warning others about fluoroquinolones that she hands out <a href="http://www.saferpills.org/">Quinolone Vigilance Foundation</a> brochures at work and in her neighborhood.<br />
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On November 4th, Ms. O'Brien interviewed Rachel Brummert and Josh Rivedal about their upcoming book <a href="http://www.iampossibleproject.com/one">The i'Mpossible Project: Reengaging with Life, Creating a New You.</a><br />
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<span style="font-size: large;"><a href="http://wric.com/2015/11/04/fda-to-hear-patient-complaints-about-commonly-prescribed-antibiotics/">You can watch the story here. </a></span><br />
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Ms. Brummert shares her story in the book about becoming disabled after taking Levaquin and how she is now helping others. She was also interviewed about<a href="https://collaboration.fda.gov/p7q9g54ygww/?launcher=false&fcsContent=true&pbMode=normal"> testifying</a> at an <a href="http://www.bizjournals.com/prnewswire/press_releases/2015/10/23/MN36691">FDA hearing on fluoroquinolones</a>, which was taking place the following day.</div>
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Ms. O'Brien covered the FDA hearing on November 5. Ms. Brummert and QVF Ambassador Jonathan Furman testified in front of the FDA panel urging the FDA to strengthen warnings and protect patients from dangerous fluoroquinolone antibiotics.<br />
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Thank you Kerri O'Brien for reporting on the dangers of fluoroquinolone antibiotics and for helping the Quinolone Vigilance Foundation raise vital awareness. We appreciate all your hard work.Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-86801935223536428022015-11-09T18:22:00.001-08:002015-11-09T18:27:35.730-08:00QVF Executive Director Rachel Brummert and author Josh Rivedal interviewed on WRIC-TV<div class="separator" style="clear: both; text-align: center;">
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Rachel Brummert, Executive Director of the <a href="http://www.saferpills.org/">Quinolone Vigilance Foundation</a> and author/actor Josh Rivedal were interviewed on November 4, 2015 by WRIC-TV reporter Kerri O'Brien about their upcoming book <a href="http://www.iampossibleproject.com/one.html">The i'Mpossible Project: Reengaging with Life, Creating a New You.</a><br />
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<span style="font-size: large;"><a href="http://wric.com/2015/11/04/fda-to-hear-patient-complaints-about-commonly-prescribed-antibiotics/">Click here to watch the interview.</a></span><br />
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In the book, Rachel writes about how she became disabled after taking the fluoroquinolone antibiotic Levaquin for a sinus infection. She hopes to inspire others with her story after overcoming severe injury and disability. Rachel now focuses her pain into helping others through her work with the foundation and in telling her powerful story in the book.<br />
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Josh Rivedal, curator and author of the book, brought together 50 talented authors to share their powerful stories of overcoming overwhelming odds and how they fought their way to the other side and are now helping others through storytelling.<br />
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Thank you Kerri O'Brien and WRIC-TV for airing this story about their book. The i'Mpossible Project: Reengaging with Life, Creating a New You is due for release on January 13, 2016 and is available for pre-order using the link below.<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi_uNjqwq0t-irgXo8OviYkxYTrCD9eefo2YxsPp9NYZwxk7ybATEuQXWky_0V5m1WzNhaxVK7PEYAhmPQFsS9RwcEWI6UbnZErKa67xdhPZGmR42GUM90FS0ybxJQO_jchFBueMgMh6ag/s1600/album_WRIC012_fb.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="191" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi_uNjqwq0t-irgXo8OviYkxYTrCD9eefo2YxsPp9NYZwxk7ybATEuQXWky_0V5m1WzNhaxVK7PEYAhmPQFsS9RwcEWI6UbnZErKa67xdhPZGmR42GUM90FS0ybxJQO_jchFBueMgMh6ag/s320/album_WRIC012_fb.jpg" width="320" /></a></div>
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Related links:<br />
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<a href="http://www.saferpills.org/executive-director-rachel-brummert-is-one-of-50-authors-in-the-upcoming-book-the-impossible-project/">Quinolone Vigilance Foundation News: Executive Director Rachel Brummert one of 50 authors featured in new book. </a><br />
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<a href="http://www.bizjournals.com/prnewswire/press_releases/2015/09/16/MN02683">The i'Mpossible Project Book Press Release</a><br />
<br />
<a href="http://www.iampossibleproject.com/one">The i'Mpossible Project: Reengaging with Life, Creating a New You pre-order </a><br />
<br />
<a href="http://quinolonevigilancefoundation.blogspot.com/2015/09/guest-blog-storytelling-will-save-world.html">Guest blog by Josh Rivedal </a><br />
<br />Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-50131472863538982722015-10-21T11:24:00.000-07:002015-10-21T11:24:35.164-07:00Steven Brill exposes Johnson & Johnson in 15 part series<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgVdVATDOdDsS36rl9SeeyS5zcSRrVanF8A5Qi7jJ3NaSbefequyqQc0xZjn94L7DlpSczDgP8P3R94jHT7e2YTMTjoa849D_cQq8pwtB-HAc8K-MPCFmWjZwYmFKwXLW4mKmFi1o5WgKA/s1600/letterhead.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="117" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgVdVATDOdDsS36rl9SeeyS5zcSRrVanF8A5Qi7jJ3NaSbefequyqQc0xZjn94L7DlpSczDgP8P3R94jHT7e2YTMTjoa849D_cQq8pwtB-HAc8K-MPCFmWjZwYmFKwXLW4mKmFi1o5WgKA/s320/letterhead.jpg" width="320" /></a></div>
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The Quinolone Vigilance Foundation wishes to thank Steven Brill for his series exposing Johnson & Johnson.<br />
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To read the complete 15 part series, <a href="http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/">click here.</a><br />
<br />
Johnson & Johnson manufactures the fluroquinolone antibiotic Levaquin, a dangerous antibiotic associated with very severe adverse reactions, leaving even the most healthy individuals disabled- or worse. <br />
Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-3515126246009316442015-10-12T00:34:00.002-07:002015-10-12T00:34:28.162-07:00Raptor Pharmaceutical Completes Acquisition of Quinsair<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEij8Y-zGai3P2mQm7VUGxV_8qtVrzSovQ-lkyBhb0ltYJG0u9sl-hMrv6c-aHVAtFkve16jkr6VpDQtrHlT-rx5FiXuWdXqbQJENZV9ZsQsglOzqzObR9Y1i4bJcMH6fmgrm9PGo_MaOfQ/s1600/letterhead.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="117" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEij8Y-zGai3P2mQm7VUGxV_8qtVrzSovQ-lkyBhb0ltYJG0u9sl-hMrv6c-aHVAtFkve16jkr6VpDQtrHlT-rx5FiXuWdXqbQJENZV9ZsQsglOzqzObR9Y1i4bJcMH6fmgrm9PGo_MaOfQ/s320/letterhead.jpg" width="320" /></a></div>
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Be aware of a new fluoroquinolone antibiotic in inhalation form.<br />
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Click<a href="http://www.marketwatch.com/story/raptor-pharmaceutical-completes-acquisition-of-quinsairtm-2015-10-05"> here</a>: <br />
Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com1tag:blogger.com,1999:blog-8086352544375605396.post-32547746187761382452015-10-04T15:46:00.001-07:002015-10-04T15:49:16.332-07:00"But You Don't Look Sick": Fluoroquinolone Toxicity<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj4TfuYHOLsnzHb6MsNyxFysxgQXe_S6Kqau7srLkYRCYg7iGCtkS4F9WrrdNxOWjIiE9ndNDYzhn4WDy0ZVKmzr6BCW9C5tm90kSk0_5C_Yd-N9mkc9KaI-rmG0cnRHKOP-xiR9sRUe-g/s1600/letterhead.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="117" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj4TfuYHOLsnzHb6MsNyxFysxgQXe_S6Kqau7srLkYRCYg7iGCtkS4F9WrrdNxOWjIiE9ndNDYzhn4WDy0ZVKmzr6BCW9C5tm90kSk0_5C_Yd-N9mkc9KaI-rmG0cnRHKOP-xiR9sRUe-g/s320/letterhead.jpg" width="320" /></a></div>
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Fluoroquinolone Toxicity is an invisible illness. Victims share their stories to shine a spotlight on what invisible illness looks like. <br />
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<iframe allowfullscreen="" frameborder="0" height="270" src="https://www.youtube.com/embed/bof4-Uyt7ME" width="480"></iframe>Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-80101494621674021992015-09-16T08:25:00.003-07:002015-09-16T08:25:23.968-07:00Guest blog: Storytelling will Save the World… Yes, Even Yours<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhQdSe_7w_VdBur3r_CugQG4P_khqH0F3f-CGlyEG-kCwmml5ibimipLdJk8OS3pvtA7nTfnZC3r_DHagfbvDygE9jOZUXypYmcXnrZJaKlM3bMwQEqQ9BDpidX9JFQYfi53n6fwWieMow/s1600/letterhead.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="117" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhQdSe_7w_VdBur3r_CugQG4P_khqH0F3f-CGlyEG-kCwmml5ibimipLdJk8OS3pvtA7nTfnZC3r_DHagfbvDygE9jOZUXypYmcXnrZJaKlM3bMwQEqQ9BDpidX9JFQYfi53n6fwWieMow/s320/letterhead.jpg" width="320" /></a></div>
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<span style="font-size: large;">Storytelling will Save the World… Yes, Even Yours</span><br />
<span style="font-size: x-small;">By Josh Rivedal</span><br />
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Captain’s log, Stardate January 2011. Where unfortunately many have gone before. I’m twenty-six years old and thinking about dying… actually I’m not being entirely truthful. I’m dangling halfway out the fourth floor window of my bedroom in New York City.<br />
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I don’t really want to die. I just want the emotional pain to stop… and I don’t know how to do that. Hell, two guys in my life—my father and grandfather—each didn’t know how to make their own terrible personal pain stop and now both were, well, dead.<br />
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My grandfather, Haakon—a Norwegian guy who served in the Royal Air Force (35th Squadron as a tail gunner) in World War II—killed himself in 1966 because of the overwhelming post traumatic stress he suffered because of the war.<br />
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My father, Douglas—an American guy who was chronically unhappy and an abusive man—killed himself in 2009, the catalyst being a divorce with my mother along with some long-term depression and other mental health issues.<br />
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How did I get to such a dismal place in my life so quickly, just a month shy of my twenty-seventh birthday? Coming out of secondary school and high on optimism, I thought by the time I reached my mid-twenties I’d have it all together. After a couple of years singing on Broadway, I would have scored a few bit parts on Law & Order, and transitioned seamlessly to being cast with Will Smith in the summer’s biggest blockbuster. After which, my getaway home in the Hamptons would be featured in Better Homes & Gardens, and my face would grace the cover of National Enquirer as Bigfoot’s not-so-secret lover. Not to mention, I’d have my perfect wife and perfect family by my side to share in my success.<br />
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But instead, “perfect” was unattainable (it always is). I only managed to perform in some of small professional theatre gigs and on one embarrassing reality television show; and over the course of the previous eighteen months my father killed himself, my mother betrayed me and sued me for my father’s inheritance, and my girlfriend of six years broke up with me.<br />
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This storm of calamity and crisis had ravaged my life… and I wasn’t talking about it to anyone. My silence led to crisis and poor decisions—to the extent that I was hanging out of a fourth story window.<br />
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Both Haakon and Douglas suffered their pain in silence because of the stigma surrounding talking about mental illness and getting help. I too felt that same stigma—like I’d be seen as “crazy” or “less of a man” if I talked about what I was going through. But I didn’t want to die and so I had to take a chance.<br />
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I started talking. I pulled myself back inside and first called my mom. She helped me through that initial crisis and we became friends again. She never called me “crazy.” I then started reaching out to the positive friends I had in my life. They hugged me and helped me with open arms. They never told me I was “less than a man.” Soon I got more help by seeing a professional counselor, and by writing down what I was going through in a journal.<br />
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But this idea of keeping silent continued to bother me. I did some research while in my recovery and found out that each year, suicide kills over one million people worldwide… and that many of those one million never speak up about their emotional pain because of stigma.<br />
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I had to figure out a way to reach people like that. So, like any other actor, writer, or comedian living in New York City whose life dealt them a crappy hand, I created a one-man show… and it toured theatres and universities in the United States, Canada, England, and Australia—and people were getting help.<br />
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But I had to keep talking because this isn’t just a Rivedal problem or United States problem… it’s a world problem.<br />
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I had to get other people to tell their stories, so I started The i’Mpossible Project. Why? Because storytelling is one of our oldest traditions—yes, even older than the hokey pokey. Stories can make us laugh or cry… or both at the same time. They can teach, inspire and even ignite an entire movement. <br />
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The stories of The i’Mpossible Project are about overcoming obstacles, reengaging with life, and creating new possibilities—a son’s homicide, a transgender man finding love, and even coming back from the brink of suicide (you can read a couple of the stories <a href="http://www.iampossibleproject.com/uploads/2/7/4/0/27408213/imp_sample_chapters_master_%28with_almost_preorder%29.pdf">HERE</a>)… because it’s okay to be struggling, it’s okay to need help; people have your back… there’s hope.<br />
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While searching for other movers and shakers, people who have a powerful story—I came across <a href="https://www.linkedin.com/profile/view?id=AAMAAAwLzM4BtRq8mSIXhFgZgpj_6Ds4dPTarC8&trk=hp-identity-name">Rachel Brummert</a> and the <a href="http://www.saferpills.org/">Quinolone Vigilance Foundation</a>. Talk about someone who has been to hell (several times… phew) and back all because of one antibiotic, a quinolone called Levaquin that turned out to be poisonous. Rachel fought hard, and is still fighting, taking care of the harmful physical effects Levaquin had on her body, and then using her experience to help others. This is the beauty of the human experience and the power of storytelling. This is why I had to have Rachel as one of the fifty authors in the new i’Mpossible Project book. <br />
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It’s been four years since my own crisis and life is definitely looking up. The acting and writing thing is going well, I have a great girlfriend; but most important I’m able to give and receive help and love, and with hard work I’m able to stay mentally well—all because I took a risk and told my story.<br />
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No matter what society says, it’s COOL (as in “okay”) to tell your story. Don’t ever forget that you are important, and your story needs to be heard so we, the human race, can learn how to live and love better. #iampossible <br />
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Effective September 16, 2015, you can pre-order a copy of the new The i’Mpossible Project book at <a href="http://www.iampossibleproject.com/one">www.iampossibleproject.com/one</a>. The book will be released on January 13, 2016.<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEir11kvdhfcdeeF1SPwNiXk6XtO-6ZZablJ0kyeAk8NkdhSCGK0n6NbU6_veGP0yveg2np7qIsWtzYq4ijlzWJOVMp4WLTGRINs2y3n6u1WlCUrCwQdg3tJ4pPXJDNUVmSsffzFvH6rdog/s1600/I%2527MPOSSIBLE_BOOK_COVER%2528sm%2529.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEir11kvdhfcdeeF1SPwNiXk6XtO-6ZZablJ0kyeAk8NkdhSCGK0n6NbU6_veGP0yveg2np7qIsWtzYq4ijlzWJOVMp4WLTGRINs2y3n6u1WlCUrCwQdg3tJ4pPXJDNUVmSsffzFvH6rdog/s320/I%2527MPOSSIBLE_BOOK_COVER%2528sm%2529.jpg" width="213" /></a></div>
<b>Press Release: <a href="http://www.bizjournals.com/prnewswire/press_releases/2015/09/16/MN02683">http://www.bizjournals.com/prnewswire/press_releases/2015/09/16/MN02683 </a></b><a href="http://www.bizjournals.com/prnewswire/press_releases/2015/09/16/MN02683"><br /></a><br />
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<span style="font-size: large;">About the Author</span><br />
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<span style="font-size: x-small;">Josh Rivedal (founder, executive director of The i'Mpossible Project) is an author, actor, playwright, and international public speaker on suicide prevention, mental health, and diversity. He curated the 50-story inspirational anthology <a href="http://www.iampossibleproject.com/one.html">The i’Mpossible Project: Reengaging With Life Creating a New You</a>. He wrote and developed the one-man play, Kicking My Blue Genes in The Butt (KMBB), which has toured extensively throughout the U.S., Canada, and the U.K. He writes for the Huffington Post. His memoir The Gospel According to Josh: A 28-Year Gentile Bar Mitzvah, based on KMBB and published by Skookum Hill in 2013, is on The American Foundation for Suicide Prevention’s recommended reading list.</span><br />
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<span style="font-size: x-small;"><b>* * *</b></span><br />
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<span style="font-size: small;">About Rachel Brummert</span><br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgzFjusEi2r1dWDxpMRfgtgY15cUPW4hQMzrBxjviYUsJ1IZ1GZ_iMDLTKMGgDX1SrJh2vE6SsmJvcViUiVS0ONc4yqhwvF_aKGlcUnccqjLae9ku39MrBXOgEGFO7nHt8Grcswhr55cVo/s1600/20150914_185111-1.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgzFjusEi2r1dWDxpMRfgtgY15cUPW4hQMzrBxjviYUsJ1IZ1GZ_iMDLTKMGgDX1SrJh2vE6SsmJvcViUiVS0ONc4yqhwvF_aKGlcUnccqjLae9ku39MrBXOgEGFO7nHt8Grcswhr55cVo/s200/20150914_185111-1.jpg" width="141" /></a></div>
<span style="font-size: x-small;">Rachel Brummert, one of 50 authors in the </span><span style="font-size: x-small;">The i’Mpossible Project: Reengaging With Life Creating a New You book, is Executive Director of the Quinolone Vigilance Foundation. She became disabled after taking the fluoroquinolone antibiotic Levaquin in 2006, which was inappropriately prescribed to her. Ms Brummert shares her story of Fluoroquinolone Toxicity and how she worked to overcome it. 100% of the proceeds from Ms Brummert's participation in the book will be donated to the<a href="http://www.saferpills.org/"> Quinolone Vigilance Foundation.</a></span><br />
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<span style="font-size: x-small;"><b>Note from the Quinolone Vigilance Foundation: It is a well established fact that fluoroquinolone antibiotics such as <a href="http://www.saferpills.org/contact/media-inquiries/quinolone-vigilance-foundation-supports-citizen-petition-requesting-another-black-box-warning-levaquin-cipro-avelox/">Avelox, Cipro, and Levaquin can cause depression, anxiety, and suicidal thoughts.</a> In addition, people who suffer adverse reactions from these toxic medications can be in enormous pain, which also lead to suicidal thoughts. We have compiled a<a href="http://quinolonevigilancefoundation.blogspot.com/2015/05/suicide-hotlines.html"> list of suicide hotlines in the United States and worldwide</a>. If you have suicidal thoughts, we urge you to reach out to a hotline in your geographic location. </b></span><br />
<br />Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com1tag:blogger.com,1999:blog-8086352544375605396.post-21818812983689832462015-09-06T17:41:00.001-07:002015-09-06T17:41:33.627-07:00What I Want People To Know About Fluoroquinolone Toxicity <div class="separator" style="clear: both; text-align: center;">
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Explaining fluoroquinolone toxicity can be challenging. At Quinolone
Vigilance Foundation, we hear from many people who are affected by
fluoroquinolones, and many of us within the foundation have been
affected ourselves.<br />
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We have compiled some information that we “floxies” want you to know about Fluoroquinolone Toxicity.<br />
<br />
<br />
<br />
<strong>Everyone is different</strong><br />
<br />
<ul>
<li>The adverse reactions run the spectrum. What one person experiences can vary greatly from someone else.</li>
</ul>
<br />
<br />
<br />
<strong>Physical and emotional toll</strong><br />
<strong></strong><br />
<ul>
<li>Fluoroquinolone toxicity can steal my self worth every day. It keeps me from things I enjoy and things I need to do. </li>
</ul>
<br />
<ul>
<li>My
“good” days are not the same as your good days. In my world, a good
day might mean I don't cry from pain, or it might mean I made it off
the couch for a few minutes. On a really good day it might mean that I
can make it to the store and there is no guarantee of when I will be
able to do that again. It varies from day to day. Sometimes even minute
to minute.</li>
</ul>
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<br />
<strong>The role of family and friends</strong><br />
<br />
<ul>
<li>I
can't control when I will have a flare-up. I could have a flare up
minutes before I have plans, and I am not using it as an excuse to
cancel plans. I need you to not take it personally and be
understanding. I hate it just as much as you do, if not more.</li>
</ul>
<ul>
<li>This
requires my loved ones to be understanding and open minded. Not
everyone can be and that is detrimental to my health if I have to
battle this alone.</li>
</ul>
<br />
<ul>
<li><span class="fbUnderline"><em><strong>THIS IS A REAL CONDITION </strong></em> </span>with
research and data backing it up. Do not reject something you do not
understand and if you want to help me, please educate yourself about
what I am going through.</li>
</ul>
<br />
<ul>
<li>The most important and helpful thing you could do for me is <span class="fbUnderline"><strong>BELIEVE ME</strong></span>.</li>
</ul>
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<strong>The struggle is real</strong><br />
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<ul>
<li>Fluoroquinolone toxicity can injure, disable, and kill. It is a serious condition that has no blanket treatment and no cure.</li>
</ul>
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<ul>
<li>It does not change who I am. It does change what I can do.</li>
</ul>
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<strong>It's not what you think</strong><br />
<br />
<ul>
<li>I am not lazy and I am not making this up.</li>
</ul>
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<ul>
<li>I did not choose this. It happened to me because I was not warned by my doctor and I may pay for that for the rest of my life.</li>
</ul>
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<ul>
<li>Fluoroquinolone
toxicity is an invisible illness, just like 96% of chronic illnesses.
I could look fine on the outside and suffer immeasurably on the
inside.</li>
</ul>
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<ul>
<li>This has no cure. The remedies
you try to push on me could actually put my health in more jeopardy.
What works for one person, could kill someone else. If I say no to the
remedy you suggest or push on me, it is not rejecting you. It is
valuing my health enough to know what could make me sicker.</li>
</ul>
<br />
<br />
<br />
<br />
I also want you to know what adverse reactions are associated with fluoroquinolones.<br />
<br />
<br />
<br />
<strong>Adverse Reactions Associated with Fluoroquinolones</strong><br />
<br />
<ul>
<li>Tendinitis</li>
<li>Tendon rupture</li>
<li>Ligament rupture</li>
<li>Meniscus tear in knee</li>
<li>Joint pain/popping</li>
<li>Muscle atrophy/weakness/pain</li>
<li>Degeneration of spinal disks</li>
<li>Peripheral neuropathy/nerve pain/nerve damage</li>
<li>Fatigue</li>
<li>Dental pain</li>
<li>Facial pain/numbness</li>
<li>Muscle twitching/involuntary spasms</li>
<li>Tremors</li>
<li>Insomnia</li>
<li>Brain fog</li>
<li>Anxiety/depression</li>
<li>Impaired memory</li>
<li>Speech/aphasia</li>
</ul>
<ul>
<li>Suicidal ideation</li>
<li>Seizures</li>
<li>Visual/auditory hallucinations</li>
<li>Non-allergy itching</li>
<li>Poor wound healing</li>
<li>Swallowing deficit</li>
<li>Persistent gastric problems</li>
<li>Mouth sores</li>
<li>Food/chemical sensitivities</li>
<li>Dry/itchy eyes</li>
<li>Lack of tear production</li>
<li>Visual changes</li>
<li>Retina tears</li>
<li>Vertigo</li>
<li>Tinnitus</li>
<li>Palpitations/arrhythmia</li>
<li>High/low blood pressure</li>
<li>Dysautonomia</li>
</ul>
<br />
<br />
<br />
And I want you to know the names of fluoroquinolones so that this doesn't happen to you too.<br />
<br />
<br />
<br />
<br />
<span><strong>Oral</strong></span><span> Fluoroquinolones</span><br />
<ul>
<li>Avelox (moxifloxacin)</li>
<li>Cipro (ciprofloxacin)</li>
<li>Factive (gemifloxacin)</li>
<li>Floxin (ofloxacin)</li>
<li>Levaquin (levafloxacin)</li>
<li>Noroxin (norfloxacin)</li>
<li>Maxaquin (lomefloxacin)</li>
<li>Penetrex (enoxacin)</li>
</ul>
<br />
<span>Fluoroquinolone <strong>Eye Drops</strong></span><br />
<ul>
<li>Besivance (besifloxacin)</li>
<li>Cetraxal, Ciloxan (ciprofloxacin)</li>
<li>Iquix, Quixin (levofloxacin)</li>
<li>Ocuflox (ofloxacin)</li>
<li>Vigamox (moxifloxacin)</li>
<li>Zymar (gatifloxacin)</li>
<li>Moxeza (moxifloxacin)</li>
</ul>
<br />
<span>Fluoroquinolone <strong>Ear Drops</strong></span><br />
<ul>
<li>Cetraxal, Ciprodex (ciprofloxacin)</li>
<li>Floxin (ofloxacin)</li>
<li>Xtoro (finafloxacin)</li>
</ul>
<span><strong>Veterinary</strong></span><span> Fluoroquinolones</span><br />
<ul>
<li>Advocin, Advocid (danofloxacin)</li>
<li>Baytril (enrofloxacin)</li>
<li>Dicural, Vetequinon (difloxacin)</li>
<li>Floxasol, Saraflox, Sarafin (sarafloxacin)</li>
<li>Ibaflin (ibafloxacin)</li>
<li>Marbocy, Zeniquin (marbofloxacin)</li>
<li>Orbax, Victas (orbifloxacin)</li>
</ul>
<br />
<br />
<br />
For more information, go to <a href="http://www.saferpills.org/" rel="nofollow" target="_blank">www.SaferPills.org</a>Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-55227082827895008612015-09-01T16:25:00.001-07:002015-09-01T16:25:20.344-07:00Washington Post article about Fluoroquinolone Toxicity by Idelle Davidson<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjPXOfC4gsnYi3SOb2g8nnxBHE7vlqlFjVHW8Oy3PYiNY0baOaxLyNkXkArKeJ6vO6CQil8TC2hIqIZ6Sr1e5n9oG18KCxbIqxkaeRgmyBkI2nDtPWDr3igJOcK2nx74wrXuHGsDq62mHY/s1600/letterhead.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="117" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjPXOfC4gsnYi3SOb2g8nnxBHE7vlqlFjVHW8Oy3PYiNY0baOaxLyNkXkArKeJ6vO6CQil8TC2hIqIZ6Sr1e5n9oG18KCxbIqxkaeRgmyBkI2nDtPWDr3igJOcK2nx74wrXuHGsDq62mHY/s320/letterhead.jpg" width="320" /></a></div>
<br />
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<br />
<br />
<br />
Excerpt from Washington Post article 'It pays to read the warnings when you open up a prescription' by Idelle Davidson. To read the full article,<a href="http://www.washingtonpost.com/national/health-science/it-pays-to-read-the-warnings-when-you-open-up-a-prescription/2015/08/03/a29e11b4-d70e-11e4-b3f2-607bd612aeac_story.html?tid=hpModule_9d3add6c-8a79-11e2-98d9-3012c1cd8d1e"> click here </a><br />
<br />
<b><i>"Plaintiffs
claim that the company failed to adequately warn physicians of the risk
of tendon injuries associated with Levaquin, a drug with about
$1.3 billion in sales in the United States in 2010. Most cases have been
settled or dismissed.</i></b><br />
<br />
<br />
<b><i> </i></b><b><i>Separately, about 60 product liability cases
are pending in federal court against Johnson & Johnson and against
Bayer for Cipro and Avelox, alleging their products caused irreversible
peripheral neuropathy or nerve damage and were sold without adequate
warnings of risk. Helping coordinate the effort is the patient advocacy
group<a href="http://www.saferpills.org/"> Quinolone Vigilance Foundation</a>. </i></b><br />
<br />
<b><i> </i></b><b><i><a href="https://www.linkedin.com/profile/view?id=AAMAAAwLzM4BtRq8mSIXhFgZgpj_6Ds4dPTarC8&trk=hp-identity-name">Rachel Brummert</a>, executive
director of the foundation, says the pharmaceutical industry should do
more to warn physicians of the risk of injury. “Doctors are largely in
the dark,” she says. “The few patients who are warned are not told that
these adverse reactions can be permanent.”</i></b><br />
<br />
<br />
<br />
This article has been picked up by <a href="http://www.tulsaworld.com/opinion/idelle-davidson-the-risky-business-of-taking-antibiotics/article_bcce562a-bd78-5d92-b156-6926115be61c.html?TNNoMobile">Tulsa World</a><b><i> </i></b>and the <a href="http://www.courant.com/consumer/hc-ls-antibiotics-drug-reaction-20150821-story.html">Hartford Courant</a>.<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi-XKn3gfP3jENY-alkxu3GTbncDvgjIu0i8PKv9dkyNwZvaHd6i7KyUQKUj1sIdppMqJyy6YbyVQtg1wbByRO3mlvm3xzkCArqacASke8hE7JnEi3diurHPyePOArLmfMk4Jqa-ZT_29E/s1600/hartford.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi-XKn3gfP3jENY-alkxu3GTbncDvgjIu0i8PKv9dkyNwZvaHd6i7KyUQKUj1sIdppMqJyy6YbyVQtg1wbByRO3mlvm3xzkCArqacASke8hE7JnEi3diurHPyePOArLmfMk4Jqa-ZT_29E/s320/hartford.jpg" width="176" /></a></div>
<div style="text-align: center;">
<br /></div>
<br />
<br />
<span style="font-size: x-small;">Author Idelle Davidson Davidson writes about health and is co-author of “<a href="http://www.amazon.com/gp/product/0738213918?ie=UTF8&camp=1789&creativeASIN=0738213918&linkCode=xm2&tag=thewaspos09-20">Your Brain After Chemo: A Practical Guide to Lifting the Fog and Getting Back Your Focus</a>.”</span><br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjWjuLsUH3Cs5ZXkueBL8FWy_pEUnj3GLuf1ZtzYBK3i1ifbtYn3zS15fqcNyog9fV5OSdsZPOsHhKmLjn6ikdYyH-Iok2XQvLPWSHW5gn7xij1pD0bi4EVh3vhU6B0_zWAxOE8_SGBvV8/s1600/idelle.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjWjuLsUH3Cs5ZXkueBL8FWy_pEUnj3GLuf1ZtzYBK3i1ifbtYn3zS15fqcNyog9fV5OSdsZPOsHhKmLjn6ikdYyH-Iok2XQvLPWSHW5gn7xij1pD0bi4EVh3vhU6B0_zWAxOE8_SGBvV8/s320/idelle.jpg" width="240" /></a></div>
<div style="text-align: center;">
<span style="font-size: x-small;"> Idelle Davidson</span><b><i> </i></b></div>
Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-76713604327583549652015-07-30T08:49:00.003-07:002015-07-30T08:49:31.532-07:00Antibiotic Type Poses Severe Nerve Damage Risk, FDA Says<div class="separator" style="clear: both; text-align: center;">
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<h1 class="entry-title">
Antibiotic Type Poses Severe Nerve Damage Risk, FDA Says</h1>
<div class="byline" style="width: 100%;">
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<span>By <strong>Jeff Overley</strong></span>
</div>
Law360, New York (August 15, 2013, 6:03 PM ET) -- The U.S. Food and Drug Administration
on Thursday warned that severe nerve damage can result from drugs in a
popular class of antibiotics, including those produced by Bayer AG and Johnson & Johnson, expanding a previous alert that regulators said was too vague about potential harm.<br />
<br />
In its announcement, the FDA said it would require label updates for all
fluoroquinolone antibacterial drugs, including Bayer’s Cipro and
J&J’s Levaquin, after finding that earlier cautions about the risk
of peripheral neuropathy failed to fully inform doctors and patients of
the risks.<br />
<br />
The possible nerve damage has been included on fluoroquinolone labels
since 2004, but a recent analysis found a “continued association”
between the drugs and neural harm, leading regulators to conclude that
the “potential rapid onset and risk of permanence were not adequately
described” in the original warning.<br />
<br />
Because of the “spontaneous” nature of adverse event reporting, the FDA
said it could not calculate the rate of side effects. There also were no
identifiable risk factors, with patients of all ages developing
peripheral neuropathy at far different stages of treatment, from a few
days to more than a year, the agency said.<br />
<br />
According to the Mayo Clinic,
peripheral neuropathy is characterized by painful burning or tingling,
typically in the hands and feet, and is often accompanied by diminished
sensitivity akin to wearing a thin glove or stocking.<br />
<br />
The warning only applies to oral and injectable fluoroquinolones —
topical versions are not thought to pose such risks. In 2011, more than
23 million patients used an oral fluoroquinolone, and nearly 4 million
more received an injection. Cipro and Levaquin, known generically as
ciprofloxacin and levofloxacin, accounted for the overwhelming majority
of prescriptions in both formulations.<br />
<br />
Fluoroquinolones have been the subject of unrelated warnings from the
FDA, which in 2008 slapped a "black box" warning on the drugs because of
their potential to cause tendon tears. J&J subsequently found
itself ensnared in multidistrict litigation over the issue, although it
has had some success convincing judges that its warnings were
sufficient.<br />
<br />
The FDA has previously advised doctors to avoid turning to
fluoroquinolones unless an infection is strongly believed to be
bacterial. If symptoms of peripheral neuropathy arise in patients, the
drug should be discontinued in favor of a different type of
antibacterial, unless the risks of change outweigh the benefits, the
agency said Thursday.<br />
<br />
--Editing by Philip Shea.
Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-75396581259048570992015-07-30T08:46:00.003-07:002015-07-30T08:46:29.103-07:00Janssen Ignored Nerve Damage Risk Of Levaquin, Suit Claims<div class="separator" style="clear: both; text-align: center;">
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Janssen Ignored Nerve Damage Risk Of Levaquin, Suit Claims<br /><br /><br />By Steven Trader<br />Law360, New York (June 29, 2015, 10:02 PM ET) -- Drugmaker Janssen Pharmaceuticals and parent company Johnson & Johnson were hit with a lawsuit Monday in Pennsylvania federal court alleging the drugmaker mislabeled and continued to market an antibiotic drug despite a growing body of research indicating that it led to permanent nerve damage.<br /><br />Gordon Olsommer, who was prescribed Janssen’s blockbuster fluoroquinolone antibiotic Levaquin in 2010 for a case of bronchitis and a sinus infection, contends that the drugmaker incorrectly advised consumers between 2004 and 2013 that the peripheral neuropathy side effects associated with the drug were rare and that symptoms would disappear once the drug was discontinued.<br /><br />Further, Olsommer says that even after the FDA determined the warning label was inadequate in 2013, consumers of Levaquin, whose chemical name is levofloxacin, were still advised that stopping the drug immediately upon the onset of symptoms would prevent permanent nerve damage, which contradicted the later warning that the symptoms may be irreversible in any case, according to the lawsuit.<br /><br />Olsommer says that shortly after he was prescribed Levaquin in June and July 2010, he began suffering the symptoms familiar to peripheral neuropathy, including weakness, numbness and pain in his hands and feet, and he was diagnosed with peripheral nerve damage shortly afterward.<br /><br />“As a direct and proximate result of defendants’ carelessness and negligence, plaintiff suffered severe and permanent physical and emotional injuries including, but not limited to, irreversible peripheral neuropathy,” the complaint says. “Plaintiff has endured pain and suffering, has suffered economic loss, including incurring significant expenses for medical care and treatment, and will continue to incur such expenses in the future.”<br /><br />The FDA approved Levaquin in 1996 for the treatment of bacterial infections of the skin, sinuses, kidneys, bladder or prostate, as well as infections such as bronchitis or pneumonia.<br /><br />The complaint alleges that as early as 1990 there was scientific evidence of an association between fluoroquinolones and peripheral neuropathy, and a 2001 paper published after Levaquin hit the market reported neurological side effects in 45 patients, half of them lasting more than a year.<br /><br />However, in 2004 the drugmakers altered the label of Levaquin only to state that peripheral neuropathy symptoms were rare, even after they were advised that patients were still suffering symptoms of neurological damage despite having discontinued the drug, according to the complaint.<br /><br />It wasn’t until 2013 that Levaquin’s label was updated with a phrase stating peripheral neuropathy may be irreversible, and the plaintiff points to a 2014 study of more than 6,000 cases of peripheral neuropathy published in the journal Neurology which found that “those on fluoroquinolones were at a statistically significant higher risk of developing peripheral neuropathy.”<br /><br />The plaintiff is seeking an unspecified amount of money for actual and punitive damages on claims that Johnson & Johnson and Janssen were negligent of the research and fraudulently concealed the danger of their product and are therefore liable for the resulting neurological effects.<br /><br />Representatives for the parties did not respond Monday to requests for comment.<br /><br /><br />Anonymoushttp://www.blogger.com/profile/14845667171110061789noreply@blogger.com0tag:blogger.com,1999:blog-8086352544375605396.post-30062787550915375442015-07-30T08:45:00.000-07:002015-07-30T08:45:05.016-07:00Janssen Hit With Another Levaquin Nerve Damage Suit<div class="separator" style="clear: both; text-align: center;">
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Janssen Hit With Another Levaquin Nerve Damage Suit<br /><br /><br />By Steven Trader<br />Law360, New York (July 29, 2015, 1:49 PM ET) -- Drugmaker Janssen Pharmaceuticals and distributor McKesson Corp. were slapped with a suit Tuesday in Pennsylvania federal court by a Texas woman who says the companies failed to warn her of the known dangers of an antibiotic drug that ultimately gave her permanent nerve damage.<br /><br />Catherine Farmer, who was administered the Johnson & Johnson unit's blockbuster fluoroquinolone antibiotic Levaquin both during and after heart surgery in 2006, contends in her complaint that rather than warning patients and physicians directly that the drug may result in permanent nerve damage, the drugmakers relied on a confusing label that between 2004 and 2013 advised consumers the side effect was rare and symptoms would disappear by discontinuing use.<br /><br />Farmer's is the second suit in about a month claiming Janssen ignored the risk of nerve damage related to Levaquin, which in 2007 was ranked as one of the top prescribed and highest-selling drugs in the world, generating $1.6 billion in revenue for Johnson & Johnson.<br /><br />Farmer says within weeks of receiving a Levaquin IV and pill prescription following her surgery she began to experience pain and numbness in her arms and legs, according to the complaint. By 2008 she was on disability and unable to work. To this day Farmer experiences burning in her arms and legs and tingling in her scalp, “as if it is on fire,” despite taking medication to help her live with her peripheral neuropathy symptoms, according to the complaint.<br /><br />Farmer's attorney Ahmed Diab of Gomez Trial Attorneys said one of the cruxes of the complaint, as in some others, is that not only were the patients not adequately warned but the physicians weren't either. Diab said patients like Farmer would call their doctors complaining of pain, only to be told to finish the course of medication then see if the pain goes away.<br /><br />"Even the doctor's weren't adequately warned, so they couldn't even advise patients in a proper manner," Diab told Law360. "Ms. Farmer just never had a shot at knowing this was a potential risk."<br /><br />The U.S. Food and Drug Administration approved Levaquin — whose chemical name is levofloxacin — in 1996 for the treatment of bacterial infections of the skin, sinuses, kidneys, bladder or prostate, as well as infections such as bronchitis or pneumonia.<br /><br />The complaint alleges that as early as 1990 there was scientific evidence of an association between fluoroquinolones and peripheral neuropathy, and a 2001 paper published after Levaquin hit the market reported neurological side effects in 45 patients, half of them lasting more than a year.<br /><br />However, in 2004 the drugmakers altered the label of Levaquin only to state that peripheral neuropathy symptoms were rare, even after they were advised that patients were still suffering symptoms of neurological damage despite having discontinued the drug, according to the complaint.<br /><br />In 2013, the FDA warned that severe nerve damage can result from the drugs included in J&J’s Levaquin and required label updates, finding that earlier cautions about the risk of peripheral neuropathy failed to fully inform doctors and patients of the risks.<br /><br />"There are a lot of cases like this being filed," said Diab. "I think we've hit a critical mass."<br /><br />In her suit Farmer alleges Janssen, Johnson & Johnson and McKesson negligently developed the drug, failed to warn users of its dangerous effects and knowingly placed it into the stream of commerce despite its defect, then fraudulently concealed information about it from its users. She seeks an unspecified amount of compensatory and punitive damages.<br /><br />Representatives Janssen and McKesson on Wednesday didn’t immediately return a request for comment. Counsel information for the defendants wasn’t immediately available.<br /><br />Farmer is represented by Joseph G. Sauder and Matthew D. Schelkopf of Chimicles & Tikellis LLP, and John H. Gomez, John P. Fiske and Ahmed S. Diab of Gomez Trial Attorneys.<br /><br />The case is Catherine and Timothy Farmer v. Johnson & Johnson, Janssen Pharmaceuticals Inc., and McKesson Corp., case number 3:02-at-06000, in the U.S. District Court for the Middle District of Pennsylvania.<br /><br />--Editing by Jeremy Barker. <br />
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