FDA is updating healthcare professionals about its continuing review of safety data for cefepime, a broad-spectrum cephalosporin antibiotic sold as Maxipime and generics. In 2007, a meta-analysis published in the literature concluded that patients taking this drug experienced increased mortality compared with those taking other cephalosporin antibiotics.
FDA has analyzed additional data, and at this time has not found an increased death rate in patients taking cefepime. FDA will continue to review the possibility of increased mortality with cefepime, to include a study based on hospital discharge data. The results will be reported approximately a year from now.
FDA Patient Safety News: September 2009
For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=90#8
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