Reports of serious bleeding and deaths among patients treated for severe sepsis with a recombinant form of human activated protein C, drotrecogin alfa, have prompted the US Food and Drug Administration (FDA) to evaluate these safety concerns, according to an early communication from the agency.
According to the FDA, after a recent retrospective study suggested that patients with severe sepsis and certain concurrent risk factors for bleeding may be more likely than patients without such risk factors to experience serious bleeding when taking drotrecogin alfa activated, the agency and the drug maker decided to reevaluate the potential problems associated with this drug. A review of the medical records of 73 patients who were treated with drotrecogin alfa activated found that serious bleeding occurred in 7 of the 20 patients (35%) who had a concurrent elevated risk of bleeding compared with 2 of 53 patients (3.8%) without these factors (Gentry CA et al. Crit Care Med. 2009;37:19-25). Patients with bleeding risk factors also were more likely to die; 13 of the 20 such patients (65%) died of any cause compared with 13 of 53 (24.5%) of those without such factors.
Kuehn BM. Sepsis Drug Risks. JAMA. 2009;301(12):1217. doi:10.1001/jama.2009.374