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On June 17, 2009, the FDA updated healthcare providers about its ongoing safety review of cefepime. The initial MedWatch report, issued in November 2007, indicated that the agency was reviewing safety data for the drug after a meta-analysis had shown increased mortality among patients who had received it in randomized trials (Lancet Infect Dis 2007; 7:338).
The meta-analysis, conducted by Yahav and colleagues, included trial-level mortality data from 38 clinical trials in which cefepime was compared with other β-lactams. The authors found 30-day all-cause mortality to be higher with cefepime than with comparators in these trials (risk ratio, 1.26; 95% confidence interval, 1.08–1.49) and in a subset of 19 trials involving patients with febril…