Fluoroquinolone Label Warning Strengthened by FDA

Troy Brown, RN

July 26, 2016

The US Food and Drug Administration (FDA) approved updated labeling for fluoroquinolone antibiotics today to warn against their use in patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, unless those patients have no other treatment options.

The new labeling strengthens warnings about the risks for disabling and potentially permanent adverse effects including tendonitis and tendon rupture, central nervous system effects, myasthenia gravis exacerbation, peripheral neuropathy, prolongation of the QT interval, torsades de pointes, and phototoxicity. These effects can occur hours to weeks after exposure and can occur together.

"Fluoroquinolones have risks and benefits that should be considered very carefully," Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in an agency news 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."

Fluoroquinolones are effective in treating serious bacterial infections, but the FDA's Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee determined on November 5, 2015, that their risks outweigh their benefits in patients with uncomplicated infections who have other treatment options. The panel was particularly concerned for the potential of more than one adverse effect to occur together.

The FDA released a drug safety communication on May 12, 2016, saying that clinicians should reserve fluoroquinolones for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have no other treatment options, because of the potential for these devastating adverse effects.

The benefits of fluoroquinolone antibiotics outweigh the risks in patients with certain serious bacterial infections, including anthrax, plague, and bacterial pneumonia, and they should continue to be available for those patients, the FDA said in the news release.

FDA-approved fluoroquinolone antibiotics include levofloxacin (Levaquin, Janssen Pharmaceuticals, Inc), ciprofloxacin (Cipro, Bayer Healthcare), ciprofloxacin extended-release tablets, moxifloxacin (Avelox, Merck), ofloxacin (available only as a generic formulation), and gemifloxacin (Factive, LG Life Sciences).

The labeling changes include updates to the Boxed Warning and a revised Warnings and Precautions section describing the risk for "disabling and potentially irreversible adverse reactions that can occur together," the FDA said in its statement. The label also warns clinicians to reserve fluoroquinolones for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, as well as no other treatment options. The patient Medication Guide describes these safety issues and is required to be given to patients with each fluoroquinolone prescription.

More information is available on the FDA website.

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