In 2004, the Food and Drug Administration (FDA) added a warning to the labeling of all systemic (oral and injectable) fluoroquinolone antibiotics, including levofloxacin (Levaquin and others), ciprofloxacin (Cipro and others), and ofloxacin (previously marketed as Floxin), that the drugs could produce peripheral neuropathy. (Topical preparation of fluoroquinolones for optic and ophthalmic uses don't have this adverse effect.) A medication guide was created at that time to warn patients of this serious and potentially permanent adverse effect. Despite these efforts, the FDA has continued to receive reports of cases of fluoroquinolone-associated peripheral neuropathy, prompting the agency to conclude that the possible rapid onset of peripheral neuropathy (within a few days of starting treatment) and the risk of permanent changes from drug use were inadequately described in the labeling. Consequently, the prescribing information and the medication guide will be revised to emphasize this adverse effect more clearly. The FDA hasn't identified any particular risk factors for the development of peripheral neuropathy.

Nurses should be aware that fluoroquinolones can produce peripheral neuropathy after systemic administration. Hospitalized patients should be monitored for neurologic changes. Patients who are prescribed a fluoroquinolone to take at home should be taught to recognize the symptoms of peripheral neuropathy (pain, burning, tingling, numbness, weakness, and changes in sensitivity to light touch, pain, or temperature in the arms or legs) and to immediately report them to the prescriber if they occur. Patients who develop peripheral neuropathy shouldn't continue taking the fluoroquinolone unless, after evaluation, it's determined that the benefits outweigh the risks. In most circumstances, though, a different class of antibiotic should be substituted. Nurses should also remind patients taking fluoroquinolones that they should read the medication guide thoroughly with each filled prescription because it will contain the most current information about the drug and its adverse effects.

To read the FDA Drug Safety Communication concerning the fluoroquinolones, go to http://1.usa.gov/16eT1WS.