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Fluoroquinolones (levofloxacin, moxifloxacin, ciprofloxacin, ofloxacin, and gemifloxacin) – Enhanced Warnings in Product Labeling and Recommendation for Restricted Use

July 26, 2016

FDA recommends avoiding use of systemic fluoroquinolone antibiotics in patients with uncomplicated infections including bronchitis, sinusitis, and uncomplicated urinary tract infections. The risk of serious adverse effects from fluoroquinolones generally outweighs the benefit in these patients, unless they have no alternative treatment options. FDA previously published alerts for serious adverse effects from fluoroquinolones in 2013 for potentially permanent nerve damage and in 2008 for tendinitis and tendon rupture. New warnings for these products include the risk of severe musculoskeletal and nervous system adverse effects, including joint pain and swelling, muscle pain and weakness, anxiety, hallucinations, depression, and suicidal thoughts. These adverse effects may appear alone or in combination, and may be permanent. Effect onset may occur within hours or weeks of fluoroquinolone initiation, and symptoms may or may not improve or resolve upon discontinuation. These effects are seen with systemic use (ie, oral and parenteral dosage forms) and not with topical use (eg, ophthalmic) of fluoroquinolones. Black box warnings for these medications were updated to include the risk of severe and potentially permanent neurologic and musculoskeletal adverse effects. Other sections of the product labels were also updated to address these concerns, including Indications and Usage, Warnings and Precautions, and Medication Guides.

Currently available systemic fluoroquinolones include ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, and ofloxacin. Health care professionals should monitor patients receiving fluoroquinolones for these severe adverse effects. Immediately discontinue fluoroquinolone therapy in patients who report these effects and change to a different antibacterial drug class to complete treatment. Patients should contact their health care professional if they experience signs of these serious adverse effects, including confusion, hallucinations, paresthesia, and pain in the joints, muscles and tendons.

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July 26, 2016; May 17, 2016; University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.