Herbal Spotlight
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 drotrecogin alfa (activated) |
| Xigris |
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Pharmaceutical
company:
Eli Lilly and Company
www.lilly.com |
NEW WARNING
The Food and Drug Administration (FDA) has become aware of a retrospective study that reported an increased risk of serious bleeding and death in patients with severe sepsis and baseline risk factors for bleeding who received activated drotrecogin alfa (Xigris), a recombinant human activated protein C that's prescribed to reduce mortality in adult patients with severe sepsis who have a high risk for death.
According to the drug's prescribing information, conditions that increase the risk for bleeding include:
- low platelet count
- international normalized ratio greater than 3
- recent GI bleeding
- recent administration of thrombolytics, oral anticoagulants, glycoprotein IIb/IIIa inhibitors, or aspirin
- recent ischemic stroke
- intracranial malformation or aneurysm
- chronic severe hepatic disease
- bleeding diathesis.
The retrospective study reviewed medical records of 73 patients who received drotrecogin alfa. Serious bleeding occurred in 35% of patients who had a bleeding risk factor compared to 3.8% of patients without any bleeding risk factors. Additionally, 65% of those with a bleeding risk factor died compared to 24.5% of those without bleeding risk factors.
The FDA is collaborating with the manufacturer to review the incidence of serious bleeding events and mortality in patients who received the drug. After the review is complete, the FDA will inform the public of the results. The FDA urges health care providers and patients to report adverse reactions to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm or by phone at 1-800-332-1088.
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