Cefepime and Death: Reality to the Rescue

Cefepime is a broad-spectrum, fourthgeneration cephalosporin originally approved by the US Food and Drug Administration (FDA) in 1996 for treatment of bacteremia, pneumonia, and other serious conditions and 1 year later as monotherapy in the empiric treatment of patients with fever and neutropenia. In the years after its approval, most physicians became confident of both the efficacy and safety of the drug. However, in 2007 came a surprising turn of events. Yahav and colleagues published a meta-analysis of 38 randomized trials involving cefepime and found a statistically significant increase in the risk of death for cefepime-treated patients versus those treated with various comparator antibiotics [1]. The study was sufficiently persuasive to compel the FDA to issue an alert to clinicians to “be aware of the risks and benefits” of prescribing cefepime until a full review could be undertaken. The FDA then embarked on the arduous task of scrutinizing every available bit of clin-