PRESS RELEASE: Early Communication About an Ongoing Safety Review

Early Communication About an Ongoing Safety Review
Cefepime (marketed as Maxipime)

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue.  Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

An article in a recent issue of The Lancet Infectious Diseases has raised the question about increased mortality with the use of cefepime (Yahav D, Paul M, Fraser A et al. Efficacy and safety of cefepime: a systematic review and meta-analysis. Lancet Infect Dis 2007; 7: 338–48).  FDA is currently reviewing some safety data and has requested additional data to further evaluate the risk of death in patients treated with cefepime.  Cefepime is a broad spectrum cephalosporin antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms.  It is a member of the class of antibiotics known as β–lactams.

The article in the May 2007 issue of The Lancet Infectious Diseases describes a higher all-cause mortality in patients treated with cefepime compared to other β–lactams. Overall, the all-cause mortality was higher with cefepime than other β-lactams (risk ratio [RR] 1·26 [95% CI 1·08–1·49]) and for the subgroup of patients with febrile neutropenia (RR 1·42 [95% CI 1·09–1·84]).  

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.  FDA is working with the manufacturer of cefepime, Bristol-Meyers Squibb, to further evaluate the finding of increased mortality in patients who received cefepime.  It will take about 4 months to complete this evaluation at which time FDA will communicate the conclusions and any resulting recommendations to the public.  Until the evaluation is completed, healthcare providers who are considering the use of cefepime should be aware of the risks and benefits described in the prescribing information and the new information from this meta-analysis. 

The FDA urges both healthcare professionals and patients to report side effects from the use of cefepime to the FDA's MedWatch Adverse Event Reporting program. 

online at www.fda.gov/medwatch/report.htm [1]
by returning the postage-paid FDA form 3500 available in PDF format at www.fda.gov/medwatch/getforms.htm [2] to 5600 Fishers Lane, Rockville, MD 20852-9787
faxing the form to 1-800-FDA-0178
by phone at 1-800-332-1088