FDA Strengthens Neuropathy Warning for Fluoroquinolones


August 15, 2013

The US Food and Drug Administration (FDA) today announced that fluoroquinolone antibiotics taken orally or by injection pose the risk for permanent peripheral neuropathy, a risk that will appear on updated labels for the drugs.

There are 6 FDA-approved fluoroquinolone drugs on the market: ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin. In 2011, 23 million patients received a prescription for oral fluoroquinolone drugs from outpatient retail pharmacies; about 3.8 million hospitalized patients were billed for injectable versions of these drugs.

The topical fluoroquinolones, applied to the eyes or ears, are not known to have the risk for peripheral neuropathy, according to the FDA.

The FDA added the possibility of peripheral neuropathy to the labels of oral and injectable fluoroquinolones in 2004. The agency said it has continued to receive reports of this adverse event since then. A recent review of cases with the outcome of disability in the FDA Adverse Event Reporting System from January 1, 2003, and August 1, 2012, showed that the onset of peripheral neuropathy after the start of fluoroquinolone therapy was rapid, often within a few days, the FDA stated. Some patients who had stopped taking the drug continued to experience nerve damage symptoms for more than a year.

The agency advises clinicians to put patients receiving a fluoroquinolone drug on another class of antibiotics if they develop symptoms of peripheral neuropathy, unless the clinician believes the benefits of fluoroquinolone treatment outweigh the risks.

More information about today's announcement is available on the FDA Web site.

To report problems with fluoroquinolones, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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