Ongoing Analyses Suggest Cefepime Does Not Increase Death Risk

June 17, 2009

June 17, 2009 — Cefepime HCl injection (Maxipime, Bristol-Myers Squibb Co) does not appear to increase the risk for death compared with comparator medications as reported previously, according to a review of data by the US Food and Drug Administration (FDA).

In an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program, the FDA notified healthcare professionals that it has finished its analysis of data indicating a possible risk of higher death with cefepime, which was first reported in 2007.

According to the FDA, the most recent data "do not indicate a higher rate of death in cefepime-treated patients," and "cefepime remains an appropriate therapy for its approved indications."

Cefepime is a fourth-generation cephalosporin and member of the beta-lactam class of antibacterial drugs with an extended spectrum of activity against gram-positive and gram-negative bacteria.

In November 2007, the FDA announced that it was evaluating findings of a meta-analysis published by Yahav and colleagues in the May 2007 issue of The Lancet Infectious Diseases, which included mortality data from 38 clinical trials. The study reported that 30-day all-cause mortality was higher with cefepime compared with other beta-lactams (risk ratio [RR], 1.26; 95% confidence interval [CI], 1.08 - 1.49). Mortality risk was further elevated when only studies including febrile neutropenia were assessed, with a 42% increased risk for 30-day all-cause mortality associated with cefepime (RR, 1.42; 95% CI, 1.09 - 1.84]).

In the current FDA analysis, which included 50 additional trials not included in the Yahav study for a total of 88 trials, no statistically significant difference in mortality was observed between cefepime and the comparators.In addition, the meta-analysis of 24 febrile neutropenia trials also did not show a statistically significant increased mortality risk in cefepime-treated patients compared with those treated with comparators.

The review is ongoing, and the FDA, along with Bristol-Myers Squibb, will be conducting separate analyses of in-hospital data of antibiotic use to further evaluate this issue. The results are expected within a year.

Adverse events related to use of cefepime therapy should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

More information is available on the FDA's MedWatch Web site.

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