Cefepime Therapy and All-Cause Mortality

The findings of increased all-cause mortality associated with cefepime therapy reported in a 2007 meta-analysis by Yahav and colleagues in The Lancet Infectious Disease prompted an early communication by the Food Drug Administration (FDA). The FDA stated that it would review more safety data to further evaluate the risk of death to patients treated with cefepime. The meta-analysis' conclusion and the FDA early communication have stirred up debates in many institutions about how to properly adjust their antibiotic practice. Our review of the method of the meta-analyis (e. g., the method of data collection) raises questions about its conclusion; we call for additional review of the clinical data before any effort is made to limit or eliminate cefepime from the current practice guidelines. We make a number of recommendations on the appropriate use of cefepime therapy while awaiting further FDA advice.