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
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
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