JNJ Johnson and Johnson

By Thomas M. Burton 

WASHINGTON -- The Food and Drug Administration said Thursday it will require heightened warnings about serious and sometimes disabling side effects from the commonly used class of antibiotics called fluoroquinolones.

That class of medications is mostly sold now as generic drugs. But well-known brand names include Bayer AG's Cipro, generically called ciprofloxacin; and Johnson & Johnson's Levaquin, or levofloxacin. The class of antibiotics has been marketed for about three decades.

The federal agency is calling for an updated boxed warning, informing patients that the serious side effects of the medicines generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections, if patients have other treatment options.

The side effects can involve damage to tendons, muscles, joints, nerves and the central nervous system. The agency's action follows a study of the issue by the FDA's Office of Surveillance and Epidemiology, which concluded as early as 2013: "We continue to find an association between fluoroquinolone antibiotic use and disabling peripheral neuropathy."

The cases evaluated by that office included weakness, numbness, pain, discomfort, burning and tingling. This research also disclosed the case of a man who suffered a hypersensitivity reaction while taking levofloxacin and died.

Another FDA review reported a risk of cardiovascular disease and of tendon rupture.

The FDA in August 2013 issued a public warning. But it subsequently concluded that a range of seemingly unconnected problems can occur with people taking the drugs. So the agency convened a safety panel that met last November, which strongly advised the FDA to issue the more stringent warnings.

Johnson & Johnson said it is studying the FDA's statement and noted that Levaquin has been used for more than 20 years. Bayer said it is aware of the FDA statement and will work closely with the FDA on the topic.

Fluoroquinolones are very commonly prescribed. IMS Health, the drug-research firm, said there were a total of more than 36 million prescriptions written in 2014, but wasn't able immediately to provide a more recent figure.

Write to Thomas M. Burton at tom.burton@wsj.com

(END) Dow Jones Newswires

May 12, 2016 17:43 ET (21:43 GMT)

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