Xigris (Drotrecogin alfa activated): concerns of serious bleeding and increased death trigger FDA safety review

On February 4th, 2009 the FDA announced an ongoing safety review of Xigris (Drotrecogin alfa [activated]). An introduction from Wikipedia:

Drotrecogin alfa (activated) (Xigris, marketed by Eli Lilly and Company) is a recombinant form of human activated protein C ( rhAPC) that has anti-thrombotic, anti-inflammatory, and profibrinolytic properties. Drotrecogin alpha (activated) belongs to the class of serine proteases. It is used mainly in intensive care medicine as a treatment for severe sepsis.

Quoting the MedWatch alert:

Xigris (Drotrecogin alfa [activated]) – Early Communication about an Ongoing Safety Review

The finding by Gentry et al. of an increased risk of death and serious bleeding events in patients treated with Xigris who also have baseline bleeding risk factors is consistent with the information in the current product label. Prescribers should refer to the product label for the specific contraindications, warnings, and, precautions and carefully weigh the increased risk of bleeding against the benefits of Xigris.

FDA is working with the manufacturer to further evaluate the incidence of serious bleeding events and mortality in patients who received Xigris. FDA will communicate its conclusions and any resulting recommendations to the public when the review is completed, which may take several months.The FDA urges both healthcare professionals and patients to report side effects from the use of Xigris to the FDA’s MedWatch Adverse Event Reporting program.

Some additional backgroung information on the marketing of Xigris (rhAPC) that is worth reading: Surviving Sepsis — Practice Guidelines, Marketing Campaigns, and Eli Lilly, N Engl J Med. 2006.

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