Press release: New FDA Panel is a Big Win for Victims of Fluoroquinolone Antibiotics

New FDA Panel is a Big Win for Victims of Fluoroquinolone Antibiotics

Quinolone Vigilance Foundation Applauds the FDA Panel's Recommendation to Limit Fluoroquinolone Use

PR Newswire

CHARLOTTE, N.C., Nov. 12, 2015 /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.

Photo - http://photos.prnewswire.com/prnh/20151112/286639

In a recent review, the FDA refers to the constellation of adverse reactions in previously healthy individuals as "fluoroquinolone-associated disability."

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.

The panel heard powerful testimony from 35 people, including the Quinolone Vigilance Foundation's executive director Rachel Brummert and Virginia ambassador Jonathan Furman.

In her testimony, Rachel Brummert 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."

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.

According to Rachel Brummert, "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."

The complications associated with Levaquin and other fluoroquinolone antibiotics like Cipro and Avelox are severe and may be permanent and life-threatening.

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.
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.

About The Quinolone Vigilance Foundation
The Quinolone Vigilance Foundation (QVF)--www.SaferPills.org-  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.

Media Contact: Rachel Brummert, Quinolone Vigilance Foundation, rachel@saferpills.org
News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE Quinolone Vigilance Foundation

Guest blog: FDA Takes Notice of “Fluoroquinolone-Associated Disability”

*Guest blog written for Baron & Budd Law Firm. The original post can be found here:

Sinusitis, bronchitis and urinary tract infections are common infections that typically send patients to the doctor looking for relief.


Millions of prescriptions are written every year for fluoroquinolone antibiotics such as Avelox (moxifloxacin), Cipro (ciprofloxacin), and Levaquin (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.

The FDA is taking notice of this, and in a recent review, the FDA refers to this constellation of symptoms in previously healthy individuals as “fluoroquinolone-associated disability”.

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.

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.

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 here.) 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.
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.

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.
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.

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.
Anything less and more people will get hurt and that is not acceptable.

For more information about fluoroquinolones and our work at the Quinolone Vigilance Foundation, please visit our website www.SaferPills.org.

About the Author: Rachel Brummert

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.

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.

QVF Testifies at FDA Hearing on November 5, 2015

On October 23,2015 the Quinolone Vigilance Foundation announced that we were testifying at the FDA, where an unprecedented hearing was taking place to discuss fluoroquinolone antibiotics.

The joint meeting of the Antimicrobial Drugs Advisory Committee (ADMAC) and Drug Safety and Risk Management Advisory Committee convened on November 5 at which 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.

QVF Ambassador Jonathan Furman and I joined thirty-three other people who came to the FDA to share our stories and to urge the FDA to make vital changes in how fluoroquinolones are prescribed.  

Jonathan Furman and I in front of the FDA

 

QVF Ambassador Jonathan Furman testifying at the FDA- speaker #13

The speaker testimonies from all 35 speakers are available here.
The written transcript can be found here. Open Speaker testimony starts on page 211. Jonathan's testimony starts on page 256. Mine starts on page 282.

Me testifying at the FDA

I was speaker #21

  

This was mine:

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.



Slide one:

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.

Slide two

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.

Slide three

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.

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.


Slide four

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.

Thank you for your time and consideration and for holding this very important meeting.

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.

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.

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.  

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.

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.

Rachel Brummert
Executive Director
Quinolone Vigilance Foundation
www.SaferPills.org

QVF honors WRIC reporter Kerri O'Brien

The Quinolone Vigilance Foundation honors WRIC-TV reporter Kerri O'Brien for her continuing coverage on the dangers of fluoroquinolone antibiotics.

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.

You can watch the story here.
The first video is the short verson; the second video is the long version.


 

Ms. O'Brien is so passionate about warning others about fluoroquinolones that she hands out Quinolone Vigilance Foundation brochures at work and in her neighborhood.

On November 4th, Ms. O'Brien interviewed Rachel Brummert and Josh Rivedal about their upcoming book The i'Mpossible Project: Reengaging with Life, Creating a New You.


You can watch the story here. 

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 testifying at an FDA hearing on fluoroquinolones, which was taking place the following day.

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.

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.

QVF Executive Director Rachel Brummert and author Josh Rivedal interviewed on WRIC-TV

Rachel Brummert, Executive Director of the Quinolone Vigilance Foundation and author/actor Josh Rivedal were interviewed on November 4, 2015 by WRIC-TV reporter Kerri O'Brien about their upcoming book The i'Mpossible Project: Reengaging with Life, Creating a New You.

Click here to watch the interview.

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.

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.

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.

Related links:

Quinolone Vigilance Foundation News: Executive Director Rachel Brummert one of 50 authors featured in new book. 

The i'Mpossible Project Book Press Release

The i'Mpossible Project: Reengaging with Life, Creating a New You pre-order  

Guest blog by Josh Rivedal