FDA still reviewing cefepime safety risk

WASHINGTON, May 14 (UPI) -- The U.S. Food and Drug Administration said it has not completed a review of safety data concerning increased mortality in patients being treated with cefepime.

The FDA announced Nov. 14, 2007, it was reviewing safety data that raised concerns about a potential increased mortality in patients treated with the drug, which is marketed as Maxipime. The FDA said it has not yet received all the data it requested from the manufacturer, Bristol-Meyers Squibb.

Officials had expected the preliminary review to take about four months, but the FDA said it has not reached a definitive conclusion as to whether the increased mortality seen with cefepime, compared with that of similar antibiotics observed in the original meta-analysis, is due to cefepime.

Cefepime is a broad spectrum cephalosporin antibiotic and is the only anti-bacterial approved as empiric monotherapy for febrile neutropenia.

The FDA urged healthcare professionals and patients to report side effects from the use of cefepime to the FDA's MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm or by telephone at 800-332-1088.