FDA neuropathy warning on fluoroquinolones

Drug labels and Medication Guides for all fluoroquinolone antibacterial drugs should be updated to better describe the serious side effect of peripheral neuropathy, a nerve disorder occurring in the arms or legs, according to an FDA Drug Safety Communication. The nerve damage, which may occur shortly after these drugs are taken, could be permanent.

“This is actually a pretty significant side effect and, although it is rare, because the quinolones are such commonly used antibiotics, this advisory is of added importance,” said James M. Wooten, PharmD, associate professor, department of medicine, section of clinical pharmacology, University of Missouri-Kansas City. “The other thing that makes it significant is that it may be a permanent effect. Just discontinuing the drug does not make this side effect go away. Patients should be instructed by both their physician and pharmacist to contact their healthcare provider if they experience any type of pain, numbness, tingling, or weakness in any extremity.”

According to FDA, the risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.

Pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position, are all symptoms of peripheral neuropathy. If a patient experiences any of these, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk. Peripheral neuropathy is a nerve disorder occurring in the arms or legs. Symptoms include pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain, or temperature, or the sense of body position.

FDA states that it will continue to evaluate the safety of drugs in the fluoroquinolone class and will communicate with the public again if additional information becomes available.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online: www.fda.gov/MedWatch/report.htm

• Download form or call (800) 332-1088 to request a reporting form, then complete and return to the address on the preaddressed form or submit by fax to 800-FDA-0178.