FDA issues safety warning on fluoroquinolone antibiotics

Based on a recent safety review, the US Food and Drug Administration (FDA) today warned clinicians that the serious side effects of fluoroquinolone antibiotics outweigh the benefits for treating sinusitis, bronchitis, and uncomplicated urinary tract infections.

In a statement today, the agency said fluoroquinolones should be used only for patients with those conditions who don't have other treatment options.

The FDA's safety review found that when used in tablet, capsule, or injectable form, the drugs are associated with disabling and potentially permanent side effects that can occur in combinations, affecting tendons, joints, muscles, nerves, and the central nervous system.

Based on the findings, the FDA will require that drug labels and medication guides for all fluoroquinolone antibiotics include the new safety information. It said its probe of the safety issues is continuing and it will issue more updates when new information is available.

The FDA aired earlier concerns about the drug side effects in 2008 and 2013, and its advisory committee discussed the issue at a meeting in November 2015.

Patients should immediately report any serious side effects from fluoroquinolones to their health providers, the FDA said. It also advised clinicians to stop treatment if patients report serious side effects and to switch to an alternative drug to complete treatment.

Affected individuals and their medical teams should report side effects from fluoroquinolones or other drugs to the FDA MedWatch program.

See also:

May 12 FDA statement

FDA MedWatch program

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