Wednesday, September 16, 2015
Guest blog: Storytelling will Save the World… Yes, Even Yours
Storytelling will Save the World… Yes, Even Yours
By Josh Rivedal
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
But I had to keep talking because this isn’t just a Rivedal problem or United States problem… it’s a world problem.
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.
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 HERE)… because it’s okay to be struggling, it’s okay to need help; people have your back… there’s hope.
While searching for other movers and shakers, people who have a powerful story—I came across Rachel Brummert and the Quinolone Vigilance Foundation. 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.
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.
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
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Effective September 16, 2015, you can pre-order a copy of the new The i’Mpossible Project book at www.iampossibleproject.com/one. The book will be released on January 13, 2016.
Press Release: http://www.bizjournals.com/prnewswire/press_releases/2015/09/16/MN02683
About the Author
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 The i’Mpossible Project: Reengaging With Life Creating a New You. 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.
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About Rachel Brummert
Rachel Brummert, one of 50 authors in the 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 Quinolone Vigilance Foundation.
Note from the Quinolone Vigilance Foundation: It is a well established fact that fluoroquinolone antibiotics such as Avelox, Cipro, and Levaquin can cause depression, anxiety, and suicidal thoughts. 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 list of suicide hotlines in the United States and worldwide. If you have suicidal thoughts, we urge you to reach out to a hotline in your geographic location.
Sunday, September 6, 2015
What I Want People To Know About Fluoroquinolone Toxicity
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.
We have compiled some information that we “floxies” want you to know about Fluoroquinolone Toxicity.
Everyone is different
- The adverse reactions run the spectrum. What one person experiences can vary greatly from someone else.
Physical and emotional toll
- Fluoroquinolone toxicity can steal my self worth every day. It keeps me from things I enjoy and things I need to do.
- 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.
The role of family and friends
- 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.
- 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.
- THIS IS A REAL CONDITION 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.
- The most important and helpful thing you could do for me is BELIEVE ME.
The struggle is real
- Fluoroquinolone toxicity can injure, disable, and kill. It is a serious condition that has no blanket treatment and no cure.
- It does not change who I am. It does change what I can do.
It's not what you think
- I am not lazy and I am not making this up.
- 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.
- 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.
- 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.
I also want you to know what adverse reactions are associated with fluoroquinolones.
Adverse Reactions Associated with Fluoroquinolones
- Tendinitis
- Tendon rupture
- Ligament rupture
- Meniscus tear in knee
- Joint pain/popping
- Muscle atrophy/weakness/pain
- Degeneration of spinal disks
- Peripheral neuropathy/nerve pain/nerve damage
- Fatigue
- Dental pain
- Facial pain/numbness
- Muscle twitching/involuntary spasms
- Tremors
- Insomnia
- Brain fog
- Anxiety/depression
- Impaired memory
- Speech/aphasia
- Suicidal ideation
- Seizures
- Visual/auditory hallucinations
- Non-allergy itching
- Poor wound healing
- Swallowing deficit
- Persistent gastric problems
- Mouth sores
- Food/chemical sensitivities
- Dry/itchy eyes
- Lack of tear production
- Visual changes
- Retina tears
- Vertigo
- Tinnitus
- Palpitations/arrhythmia
- High/low blood pressure
- Dysautonomia
And I want you to know the names of fluoroquinolones so that this doesn't happen to you too.
Oral Fluoroquinolones
- Avelox (moxifloxacin)
- Cipro (ciprofloxacin)
- Factive (gemifloxacin)
- Floxin (ofloxacin)
- Levaquin (levafloxacin)
- Noroxin (norfloxacin)
- Maxaquin (lomefloxacin)
- Penetrex (enoxacin)
Fluoroquinolone Eye Drops
- Besivance (besifloxacin)
- Cetraxal, Ciloxan (ciprofloxacin)
- Iquix, Quixin (levofloxacin)
- Ocuflox (ofloxacin)
- Vigamox (moxifloxacin)
- Zymar (gatifloxacin)
- Moxeza (moxifloxacin)
Fluoroquinolone Ear Drops
- Cetraxal, Ciprodex (ciprofloxacin)
- Floxin (ofloxacin)
- Xtoro (finafloxacin)
- Advocin, Advocid (danofloxacin)
- Baytril (enrofloxacin)
- Dicural, Vetequinon (difloxacin)
- Floxasol, Saraflox, Sarafin (sarafloxacin)
- Ibaflin (ibafloxacin)
- Marbocy, Zeniquin (marbofloxacin)
- Orbax, Victas (orbifloxacin)
For more information, go to www.SaferPills.org
Tuesday, September 1, 2015
Washington Post article about Fluoroquinolone Toxicity by Idelle Davidson
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, click here
"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.
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 Quinolone Vigilance Foundation.
Rachel Brummert, 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.”
This article has been picked up by Tulsa World and the Hartford Courant.
Author Idelle Davidson Davidson writes about health and is co-author of “Your Brain After Chemo: A Practical Guide to Lifting the Fog and Getting Back Your Focus.”
Idelle Davidson
Thursday, July 30, 2015
Antibiotic Type Poses Severe Nerve Damage Risk, FDA Says
Antibiotic Type Poses Severe Nerve Damage Risk, FDA Says
By Jeff Overley
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.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.
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.
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.
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.
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.
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.
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.
--Editing by Philip Shea.
Janssen Ignored Nerve Damage Risk Of Levaquin, Suit Claims
Janssen Ignored Nerve Damage Risk Of Levaquin, Suit Claims
By Steven Trader
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.
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.
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.
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.
“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.”
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.
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.
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.
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.”
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.
Representatives for the parties did not respond Monday to requests for comment.
By Steven Trader
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.
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.
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.
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.
“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.”
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.
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.
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.
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.”
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.
Representatives for the parties did not respond Monday to requests for comment.
Janssen Hit With Another Levaquin Nerve Damage Suit
Janssen Hit With Another Levaquin Nerve Damage Suit
By Steven Trader
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.
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.
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.
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.
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.
"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."
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.
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.
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.
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.
"There are a lot of cases like this being filed," said Diab. "I think we've hit a critical mass."
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.
Representatives Janssen and McKesson on Wednesday didn’t immediately return a request for comment. Counsel information for the defendants wasn’t immediately available.
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.
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.
--Editing by Jeremy Barker.
Friday, June 19, 2015
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