In 2004, Food and Drug Administration (FDA) required drug labels on fluoroquinolone-based medications to include warnings about a rare but serious side effect: peripheral neuropathy. As explained in a safety announcement released on August 15, 2013, FDA updated its label requirements for these medicines, including levofloxacin (Levaquin^®), ciprofloxacin (Cipro^®), moxifloxacin (Avelox^®), norfloxacin (Noroxin^®), ofloxacin (Floxin^®), and gemifloxacin (Factive^®), to require a more detailed description of the side effect. The reason for the change, the agency said, is that “the potential rapid onset and risk of permanence were not adequately described.” 

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. It can occur at any time during treatment and can last for months or even years after a patient stops taking the drug. In some cases, FDA added, it can be permanent.

Health care providers should be certain that patients receive a medication guide with every prescription, and that they know the risks and the symptoms. If symptoms develop, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial medication unless the benefit of continued treatment with fluoroquinolone outweighs the risk. FDA encourages health care providers to report adverse events or side effects to the MedWatch Safety Information and Adverse Event Reporting Program.