FDA Revises Warning Label on Fluoroquinolone Antibiotics

The U.S. Food and Drug Administration (FDA) has approved labeling changes on fluoroquinolone antibiotics, which include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin and gemifloxacin (Factive). In a news release issued Tuesday, the agency said the Boxed Warning and the Warning and Precautions section of the label would be revised to warn of “disabling and potentially permanent side effects” affecting tendons, muscles, joints, nerves and the central nervous system.

Fluoroquinolones fight bacterial infections by preventing growth or killing bacteria. In November 2015, an FDA Advisory Committee reviewed new safety information involving two or more side effects that occur simultaneously, and the potential to lead to permanent damage. The committee concluded that the risks of fluoroquinolones generally outweighed the benefits in patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections. In May, the FDA released a drug safety communication stating that use of fluoroquinolones should be limited to situations where no alternative treatments are available.
The new safety label will reflect current information showing that both oral and injectable fluoroquinolones were associated with “disabling side effects” that can affect the tendons, muscles, joints, nerves and the central nervous system, the FDA said. The agency’s news release stated that the side effects may be permanent, and occur anywhere from hours to weeks after treatment.

“Fluoroquinolones have risks and benefits that should be considered very carefully,” Dr. Edward Cox, M.D., director of the Office of Antimicrobial Products in 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.”

The FDA recommends that patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis and uncomplicated urinary tract infections should only be treated with fluoroquinolones if no other options are available. This is not the case for more serious infections, including anthrax, plague and bacterial pneumonia.
The link between permanent nerve damage and fluoroquinolones was first documented by a Belgian doctor in 1992. The FDA notified Bayer of numerous nerve damage reports in 2002.

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