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U.S. Department of Health and Human Services


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Cefepime (marketed as Maxipime) November 2007

Audience: Healthcare professionals

[UPDATE 05/14/2008] FDA is continuing its investigation of a possible association between the use of cefepime and an increased risk of mortality compared with similar drugs. FDA will communicate its conclusions and any resulting recommendations to the public at the completion of its review.

[Posted 11/14/2007] FDA issued an early communication about the ongoing review of new safety data and the request for additional data to further evaluate the risk of death in patients treated with cefepime. An article in the May 2007 issue of The Lancet Infectious Diseases (Efficacy and safety of cefepime: a systematic review and meta-analysis) raised the question about increased mortality with the use of cefepime, a broad spectrum B-lactam antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms. The article describes a higher all-cause mortality in patients treated with cefepime compared to other B-lactam antibiotics. Until FDA's evaluation is completed, healthcare professionals who are considering the use of cefepime should be aware of the risks and benefits described in the product's prescribing information and the new information from this meta-analysis.

[May 14, 2008 - Update of Safety Review - FDA]
[November 14, 2007 - Ongoing Safety Review: Cefepime - FDA]