FDA Strengthens Safety Warnings for Fluoroquinolones

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FDA Strengthens Safety Warnings for Fluoroquinolones
FDA Strengthens Safety Warnings for Fluoroquinolones

WEDNESDAY, July 27, 2016 (HealthDay News) -- The U.S. Food and Drug Administration announced Tuesday that it's strengthening label warnings on fluoroquinolones because the drugs can lead to disabling side effects, including long-term nerve damage and ruptured tendons.

The agency also cautioned that these medications shouldn't be prescribed for sinusitis, chronic bronchitis, or simple urinary tract infections unless no other treatments options exist. "Fluoroquinolones have risks and benefits that should be considered very carefully," Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "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."

A safety review revealed that potentially permanent side effects involving tendons, muscles, joints, nerves, and the central nervous system can occur hours or weeks after exposure to fluoroquinolone pills or injections. Also, two or more serious side effects can occur together, the FDA said. Because of this, the FDA recommends reserving these antibiotics for serious bacterial infections, such as anthrax, plague, and bacterial pneumonia. In these cases, "the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option," the agency said.

The new labeling action will include an updated boxed warning and revisions to the Warnings and Precautions section of the label. Also, a medication guide that patients receive describes the safety issues tied to these drugs, the agency said.

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