FDA News

FDA requires label updates for fluoroquinolone antibacterial drugs

The FDA is requiring an update to drug labels and medication guides for all fluoroquinolone antibacterial drugs to include the serious adverse effect of peripheral neuropathy, according to a press release.

Peripheral neuropathy can occur soon after the drugs are taken and may be permanent, but only occurs with fluoroquinolones that are taken by mouth or injection. Approved drugs include: levofloxacin (Levaquin, Janssen), ciprofloxacin (Cipro, Bayer), moxifloxacin (Avelox, Bayer), norfloxacin (Noroxin, Merck), ofloxacin (Floxin, Janssen) and gemifloxacin (Factive, Cornerstone). Topical formulations of the drug are not known to be associated with the risk.

If a patient develops symptoms of peripheral neuropathy, fluoroquinolone use should be stopped unless the benefit of continued treatment outweighs the risks.

The FDA is requiring an update to drug labels and medication guides for all fluoroquinolone antibacterial drugs to include the serious adverse effect of peripheral neuropathy, according to a press release.

Peripheral neuropathy can occur soon after the drugs are taken and may be permanent, but only occurs with fluoroquinolones that are taken by mouth or injection. Approved drugs include: levofloxacin (Levaquin, Janssen), ciprofloxacin (Cipro, Bayer), moxifloxacin (Avelox, Bayer), norfloxacin (Noroxin, Merck), ofloxacin (Floxin, Janssen) and gemifloxacin (Factive, Cornerstone). Topical formulations of the drug are not known to be associated with the risk.

If a patient develops symptoms of peripheral neuropathy, fluoroquinolone use should be stopped unless the benefit of continued treatment outweighs the risks.