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FDA announces safety labeling changes for fluoroquinolones

[5-12-16] Today, the FDA is requiring labeling changes for antibacterial drugs called fluoroquinolones, including an updated boxed warning, stating that the serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones are associated with disabling and potentially permanent, serious side effects that can occur together. These side effect can involve the tendons, muscles, joints, nerves and central nervous system. As a result, the FDA is also requiring label changes for all systemic fluoroquinolone antibacterial drugs to reflect this new safety information.

The FDA takes seriously its responsibility to protect the health of the American public through the review of safety, effectiveness and quality of medical products for patients. The agency continuously reviews the available sources of data to make a determination about the safety and efficacy of fluoroquinolones and will keep health care providers and the public informed of new information.

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