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U.S. Department of Health and Human Services

Safety

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Cefepime (marketed as Maxipime) Update of Ongoing Safety Review

Audience: Infectious disease healthcare professionals

FDA notified healthcare professionals that it has finished its analysis of a possible risk of higher death with cefepime, an antibiotic, following publication of a study that suggested a higher rate of death in patients treated with this drug, as compared to patients treated with similar drugs. FDA reviewed this study data and conducted additional analyses based on additional data, including data submitted by Bristol Meyers Squibb. FDA has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Cefepime remains an appropriate therapy for its approved indications.

FDA will continue to review the safety of cefepime. As part of this ongoing review, both FDA and Bristol Meyers Squib are conducting separate analyses of death potentially associated with cefepime, using hospital drug use data. The results of these analyses likely will be reported in approximately one year.

[06/17/2009 - Information for Healthcare Professionals - FDA]

Previous MedWatch safety alert:

November 2007, updated May 2008 - Cefepime (marketed as Maxipime)