Safety Alerts & Recalls

What does this mean?

If you are receiving cefepime (or the brand Maxipime), this update should provide reassurance that the use of cefepime has not been shown to increase the risk of death at this time. The FDA and Bristol Meyers Squib will continue to review the safety of cefepime by conducting evaluations of the outcomes of hospitalized patients who receive cefepime. The results of these evaluations are expected to be reported in approximately one year.

FDA Update on Ongoing Safety Review of Cefepime (Maxipime)

The FDA has finished its evaluation of a possible increased risk of death with cefepime (Maxipime). The safety review of cefepime was first announced in November 2007 and since then the FDA has reviewed data from published studies and additional data submitted by Bristol Meyers Squibb, the manufacturer of cefepime (Maxipime). The FDA has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Cefepime, an antibiotic that is administered by infusion into the vein, remains an appropriate therapy for its approved indications which include the treatment of pneumonia, urinary tract infections, skin infections, and abdominal infections.

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Source: FDA
Publication Date: 2009-06-17
Last Updated: 2009-12-05

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