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FDA conducting ongoing safety review of drotrecogin alfa
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The FDA announced earlier this week that it is conducting an ongoing safety review of drotrecogin alfa to evaluate the incidence of serious bleeding events and death reported in patients assigned the drug for severe sepsis.
The review was prompted by a study and accompanying editorial recently published in Critical Care Medicine that reported an increased risk for serious bleeding and death in patients who had baseline bleeding risk factors and were being treated with drotrecogin alfa (Xigris, Eli Lilly). A retrospective review of medical records found that 35% of patients treated with drotrecogin alfa who also had baseline bleeding risk factors had serious bleeding events while on the drug compared with only 3.8% of patients without baseline bleeding risk factors. In addition, more patients with baseline bleeding risk factors died (65%) compared with those without baseline risk factors (24.5%).
Drotrecogin alfa was already known to increase bleeding risk. The drug’s label includes a warning that describes bleeding as the most common serious adverse effect and lists a number of risk factors to carefully consider when deciding to use it. The label contraindicates the use of drotrecogin alfa in several clinical situations where bleeding could lead to significant adverse reactions or death.
The FDA is not recommending that prescribers stop administering drotrecogin alfa but encourages voluntary reporting of problems associated with the drug to MedWatch at www.fda.gov/medwatch/report.htm.