FDA releases a Follow-up to the November 14, 2007, Communication about the Ongoing Safety Review of Cefepime (marketed as Maxipime)
Update of Safety Review
Follow-up to the November 14, 2007, Communication about
the Ongoing
Safety Review of Cefepime (marketed as Maxipime)
This information reflects FDAs 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.
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. 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.
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.
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: 33848).
