FDA Issues Early Communication About Ongoing Safety Review of CefepimeA published report about increased mortality associated with the use of cefepime (marketed as Maxipime) has prompted the FDA to issue an early communication and request additional data to further evaluate the risk of death in patients treated with cefepime. The findings, reported in the May 2007 issue of The Lancet Infectious Diseases (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) describes a higher all-cause mortality in patients treated with cefepime compared to other ß–lactams. FindingsOverall, the all-cause mortality was higher with cefepime, a broad-spectrum cephalosporin antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms, than with other ß-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]).FDA’s Next StepsThe 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 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.Report Side EffectsThe 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.htmby returning the postage-paid FDA form 3500 available in PDF format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787faxing the form to 1-800-FDA-0178by phone at 1-800-332-1088