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Title: Cefepime (Maxipime) - Early Communication About An Ongoing Safety Review

"Cefepime (Maxipime) - Early Communication About An Ongoing Safety Review"

BETHESDA, MD -- November 15, 2007 -- The U.S. Food and Drug Administration (FDA) issued an early communication about the ongoing review of new safety data and the request for additional data to further evaluate the risk of death in patients treated with cefepime (Maxipime). An article in the May 2007 issue of [The Lancet Infectious Diseases ("Efficacy and safety of cefepime: a systematic review and meta-analysis") raised the question about increased mortality with the use of cefepime, a broad spectrum beta-lactam antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms. The article describes a higher all-cause mortality in patients treated with cefepime compared to other beta-lactam antibiotics.

Until FDA's evaluation is completed, healthcare professionals who are considering the use of cefepime should be aware of the risks and benefits described in the product's prescribing information and the new information from this meta-analysis.

SOURCE: U.S. Food and Drug Administration

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