Cefepime is appropriate, FDA says.(NEWS FROM THE FDA)(Brief article)

A review of data on cefepime indicates that the antibiotic is appropriate for its approved indications, despite earlier concerns that it may have been associated with an increase in mortality risk compared with other agents in its class, the FDA announced.

Cefepime, a cephalosporin antibiotic, is approved for the treatment of a variety of infections due to its extended spectrum of activity against Gram-positive and Gram-negative bacteria.

Cefepime's safety was determined based on the findings from trial-level and patient-level meta-analyses, "neither of which showed a statistically significant difference in mortality with cefepime," the announcement said.

The FDA began reviewing safety data on cefepime (Maxipime) in November 2007, and compared its mortality data with those of other beta-lactam antibacterials. A 38-trial meta-analysis indicated a 1.26 risk ratio for 30-day all-cause mortality among patient taking cefepime, compared with those taking other beta-lactam antibacterials.

In the FDA's follow-up investigation that involved additional data from the agent's manufacturer, Bristol-Meyers Squibb, data on 50 more trials were analyzed along with the initial 38 trials. All-cause 30-day post-therapy mortality rates were 6.2% for the 9,467 cefepime-treated patients and 6.0% for the 8,288 patients treated with comparison antibiotics, a difference that was not statistically significant.

According to the announcement, the FDA is continuing its investigation of cefepime and its potential mortality risk, using hospital drug utilization data. A separate investigation of this association has been requested of Bristol-Meyers Squibb. The results of these analyses are not expected for at least 1 year, according to the FDA.

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