CHARLOTTE, N.C., July 27, 2016 /PRNewswire-iReach/ -- The Food and Drug Administration (FDA) approved on July 26, 2016 strengthened warning label changes and issued a limitation-of-use directive on fluoroquinolone antibiotics, which are associated with severe and often permanent adverse reactions, also known as "fluoroquinolone associated disability".
Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA has determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options.
"Fluoroquinolones are the 'big guns' of antibiotics and should only be used for life threatening infections such as anthrax, MRSA, and sepsis. For them to be prescribed for routine infections such as urinary tract, bronchitis, and sinus infections, the risk outweighs the benefits. All it takes is as little as one pill, ear drop, or eye drop to forever alter your life and cause permanent damage," said Rachel Brummert, Executive Director of the Quinolone Vigilance Foundation (QVF).
Brummert, of Charlotte, North Carolina, is herself a patient who was prescribed Levaquin in 2006 for a suspected sinus infection. She has suffered ten tendon ruptures, brain damage, cardiac problems, peripheral neuropathy, and other adverse reactions over the last decade.
Fluoroquinolone antibiotics such as Levaquin (levofloxacin), Cipro (ciprofloxacin), and Avelox (moxifloxacin) treat bacterial infections. In a recent review, the FDA refers to the constellation of adverse reactions in previously healthy individuals as "fluoroquinolone-associated disability". A panel at an FDA hearing on November 5, 2015 listened to powerful testimony from 35 people, including Brummert.
"Victims from across the country came together and made clear to the FDA that what happened to them could happen to anyone if the FDA did not place stronger warnings on fluoroquinolone antibiotics and restrict them to the most severe cases. The Quinolone Vigilance Foundation applauds the FDA for making the right decision by adding additional and critical warnings to the label and stressing the need for vigilance when it comes to prescribing fluoroquinolones", added Brummert.
Jonathan Furman, of Richmond, Virginia, who also testified at the FDA about his experience with Cipro, agrees. "Although much more needs to be done to address the issues with fluoroquinolones and the associated and ongoing unnecessary suffering caused by the inappropriate use of these antibiotics, yesterday's FDA announcement regarding labeling changes to this entire class of drugs is welcome news. Thanks to the good work of the AMDAC committee and all who testified at the November 5, 2015 hearing the important information regarding the disabling syndrome that can result from fluoroquinolone exposure will now be available to every prescriber and patient".
The labeling changes include an updated Boxed Warning and revisions to the Warnings and Precautions section of the label about the risk of disabling and potentially irreversible adverse reactions that can occur together.
Adverse reactions from Levaquin, Avelox, Cipro, and other fluoroquinolone antibiotics include tendon rupture, aortic aneurism, mitochondrial damage, psychiatric events, peripheral neuropathy, damage to the central, peripheral, and autonomic nervous systems, neurodegenerative disorders, and more.
About The Quinolone Vigilance Foundation
The Quinolone Vigilance Foundation (QVF)--www.SaferPills.org- is an international non-profit, charitable foundation headquartered in Charlotte, North Carolina, that helps raise awareness about fluoroquinolone antibiotics and their dangers among patients and medical professionals, and funds independent research on fluoroquinolone toxicity.
Media Contact: Rachel Brummert, Quinolone Vigilance Foundation, 609-575-9839, email@example.com
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