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  1. Drug Safety and Availability

FDA approves safety labeling changes for fluoroquinolones

FDA approves safety labeling changes for fluoroquinolones

[7-26-16] Today, the FDA has approved labeling changes for antibacterial drugs called fluoroquinolones, including an updated Boxed Warning, and advising that the serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB) and uncomplicated urinary tract infections (UTIs) 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 oral and injectable fluoroquinolones for systemic use are associated with disabling and potentially permanent, serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves and central nervous system. As a result, the FDA required and approved 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.

July 26, 2016

May 12, 2016

Fluoroquinolone Antimicrobial Drugs Information