US FDA seeks more data on Bristol's cefepime risk

WASHINGTON, Nov 14 (Reuters) - The U.S. Food and Drug Administration said on Wednesday it requested more data to evaluate the risk of death in patients treated with Bristol-Myers Squibb's (BMY.N) cefepime antibiotic.

An article in the May 2007 issue of "The Lancet Infectious Diseases" described a higher mortality in patients treated with cefepime compared to other antibiotics in the same class, the FDA said.

Cefepime, which is marketed under the brand name Maxipime by Elan Corp (ELN.I), is a broad-spectrum antibiotic approved to treat a variety of infections.

"FDA is working with the manufacturer of cefepime, Bristol-Myers Squibb, to further evaluate the finding of increased mortality in patients who received cefepime. It will take about four months to complete this evaluation at which time FDA will communicate the conclusions and any resulting recommendations to the public," the agency said.

The FDA urged doctors and patients to report side effects from the use of cefepime to the agency's adverse event reporting program.

The FDA posted a notice about its ongoing safety review of cefepime here. (Reporting by Julie Vorman; Editing by Tim Dobbyn)