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Cefepime (marketed as Maxipime) Safety Review: An Update

6/17/2009

FDA 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 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. 


Background of Safety Issue: On November 14, 2007, FDA announced it was reviewing a study that suggested there may be a higher rate of death in patients treated with cefepime, an antibiotic, as compared to patients treated with similar drugs. This study analyzed the findings of multiple reports on cefepime.

FDA’s Analysis: FDA reviewed this study data and conducted additional analyses based on additional data, including data submitted by Bristol Meyers Squibb, the company that markets Maxipime.

Future Activities: 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.
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Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.

This follow-up communication is in keeping with FDA’s commitment to informing the public about its ongoing safety reviews of drugs.

 

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