FDA releases a Follow-up to the November 14, 2007, Communication about the Ongoing Safety Review of Cefepime (marketed as Maxipime)
Follow-up to the November 14, 2007, Communication about
Safety Review of Cefepime (marketed as Maxipime)
This information reflects FDAâ€™s current analysis of available data concerning this drug.
ROCKVILLE, Md., May 14, 2008--On November 14, 2007, FDA announced that it was reviewing safety data that raised concerns about a potential increased mortality in patients treated with cefepime versus similar drugs noted in a meta-analysis published by Yahav et al. 1, and that FDA had requested additional data from the manufacturer, Bristol-Meyers Squibb (BMS) (Early Communication About an Ongoing Safety Review: Cefepime (marketed as Maxipime)). FDA expected its preliminary review to take about 4 months and committed to communicate its conclusions and any resulting recommendations to the public at the completion of its review.
FDA is continuing to review safety data for the drug cefepime. Â There are a large number of studies to be reviewed and some, but not all, of the requested study data have been received by the FDA.Â As a result, FDA has not reached a definitive conclusion as to whether or not the increased mortality seen with cefepime compared to other ?-lactam antibiotics observed in the meta-analysis is due to cefepime.
Cefepime is a broad spectrum cephalosporin antibiotic approved for the treatment of infections due to susceptible strains of microorganisms. It is a member of the class of antibiotics known as ?-lactams. Cefepime is sold only as a prescription drug and it is the only antibacterial approved as empiric monotherapy for febrile neutropenia. Â
The FDA urges both healthcare professionals and patients to report side effects from the use of cefepime to the FDA's MedWatch Adverse Event Reporting program.Â
- online at www.fda.gov/medwatch/report.htm
- by returning the postage-paid FDA form 3500 available in PDF format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787
- faxing the form to 1-800-FDA-0178
- by phone at 1-800-332-1088
1 Yahav D, Paul M, Fraser A et al. Efficacy and safety of cefepime: a systematic review and meta-analysis. Lancet Infect Dis 2007; 7: 338â€“48).
Posted: May 2008