Fluoroquinolone Label Updated to Warn of Disabling, Potentially Permanent Side EffectsJul 28, 2016
The warning label on fluoroquinolone antibiotics, which include Levaquin (levofloxacin), Cipro (ciprofloxacin), ciprofloxacin extended-release tablets, Avelox (moxifloxacin), ofloxacin, and Factive (gemifloxacin), is being updated to warn of "disabling and potentially permanent side effects" affecting tendons, muscles, joints, nerves, and the central nervous system. The approved labeling changes follow a May 12th U.S. Food and Drug Administration (FDA) "Drug Safety Communication" stating that fluoroquinolones should only be used for conditions in which no other treatments are available.
The link between permanent nerve damage and fluoroquinolones was first documented by a Belgian physician in 1992; the FDA notified Bayer of numerous nerve damage reports in 2002. In November 2015, an FDA Advisory Committee determined that the risks of fluoroquinolones outweighed the benefits in patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections (UTIs). The Committee reviewed new safety information focusing on two or more side effects occurring at the same time.
The FDA news release, issued on July 26th, indicated that current information revealed that both oral and injectable fluoroquinolones were linked with "disabling side effects" that may affect the tendons, muscles, joints, nerves, and the central nervous system. These side effects may occur hours to weeks after treatment, and the effects may be irreversible. "Fluoroquinolones have risks and benefits that should be considered very carefully," Dr. Edward Cox, M.D., director of the Office of Antimicrobial Products at the FDA's Center for Drug Evaluation and Research, said in the release. "It's important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use."
According to the FDA, fluoroquinolones should only be used to treat patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs if no other alternatives are available. The cautionary measure is not advised for more serious infections, including anthrax, plague, and bacterial pneumonia.