Cefepime (Maxipime) - Ongoing Safety Review - UPDATED
June 18, 2009
FDA has completed its evaluation and analysis of the possible risk of increased mortality with cefepime (Maxipime). After evaluating several studies and data from the manufacturer, FDA has concluded cefepime does not increase the risk of mortality when compared with other antibiotics.
The original article, published in the May 2007 issue of The Lancet Infectious Diseases by Yahav et al, described an increase in mortality related to the use of cefepime. The article reported a higher all-cause mortality with cefepime compared to other beta-lactam antibiotics (risk ratio [RR] 1.26), and in a subgroup of patients with febrile neutropenia (RR 1.42). Since then, FDA has performed meta-analyses based on data from 88 clinical trials, including the original 38 articles used in the Yahav et al meta-analysis. FDA analysis of combined trial data found no significant difference in all-cause mortality with cefepime compared with a similar drug [mortality rate: cefepime 6.21% (588/9467) vs. comparator 6% (497/8288)]. Additional subgroup analyses of the 50 trials not included in Yahav et al article showed no increased mortality risk.
FDA recommends cefepime continued to be used according to package labeling. FDA and Bristol Meyers Squibb will continue monitor mortality risk using hospital drug utilization reviews. FDA urges patients and healthcare professionals to report adverse events related to cefepime use to the MedWatch Adverse Event Reporting program. This can be done online at www.fda.gov/medwatch/report.htm or by calling 1-800-332-1088.
Further information can be found at the following websites:
- Early Communication about Ongoing Safety Review:
- MedWatch Alerts
- Information for Healthcare Professionals, June2009
- Update of Safety Review, May 2008
June 18, 2009; November 20, 2007; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.