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The FDA has issued a MedWatch report acknowledging a recent retrospective study of drotrecogin alfa for treatment of severe sepsis. This study showed an increased risk for serious bleeding events and death in patients with baseline bleeding risk factors.
The MedWatch report indicates that the baseline bleeding risk factors found in the study are consistent with those noted under “specific contraindications” and “warnings and precautions” in the current prescribing information for drotrecogin alfa. The FDA is working with the manufacturer to further evaluate the incidence of serious bleeding events and death and will communicate its conclusions when the review is completed. Healthcare professionals and patients are urged to report side effect…