On May 12, 2016, the U.S. Food and Drug Administration (“FDA”) mandated that fluoroquinolone drugs add a black warnings to their professional labels and medication guides. The black box is the FDA’s strongest warning it can implement on a prescription drug’s label. An FDA safety review showed that fluoroquinolone drugs “are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.”
The FDA further commented that unless patients lack other treatment options, uncomplicated infections should NOT be treated with fluoroquinolones given the risk for disabling and potentially permanent adverse events. The FDA-approved fluoroquinolones available on the market include:
- Avelox (moxifloxacin)
- Cipro (ciprofloxacin)
- Levaquin (levofloxacin)
- Factive (gemifloxacin)
The ruling by the FDA comes on the heels of its advisory panel recommending stronger label warning for the class of drugs in November 2015. The advisory panel, after reviewing evidence and hearing testimony, voted that Avelox®, Cipro®, and Levaquin® are too risky for sinus infections. Rachel Brummert, President of the Quinolone Vigilance Foundation, testified at the hearing regarding the dangers of using fluoroquinolone drugs for routine infections. The FDA has informed Ms. Brummert that it will implement new warnings to reflect the panel’s findings.
Harford, P.C., is currently accepting cases regarding peripheral neuropathy injuries following the use of a fluoroquinolone drug. If you or someone you know has been injured by the use of a fluoroquinolone drug, please contact us today for a free consultation. You can reach us today at (212) 390-8983.
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