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2005 Safety Alert: Xigris [drotrecogin alfa (activated)] |
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The following information is from Eli Lilly. Contact the company for a copy of any referenced enclosures.RE: IMPORTANT DRUG WARNING
Dear Healthcare Professional, Eli Lilly and Company (Lilly) would like to inform you of important new safety information about Xigris. A new WARNING has been added to the prescribing information for Xigris [drotrecogin alfa (activated)], a biological therapeutic product indicated for the treatment of adult patients with severe sepsis who are at high risk of death. The warning is based upon exploratory analyses of the ADDRESS clinical trial database and subsequent reanalysis of the PROWESS (Phase 3 registration) clinical trial database. This new warning, which appears below, applies only to patients with single organ dysfunction and recent surgery. These patients may not be at high risk of death and therefore may not be indicated for Xigris.
Although not conclusive, Lilly believes this information will be useful to healthcare professionals who evaluate patients for Xigris therapy. This observation underscores the importance of accurate severe sepsis diagnosis and assessment of risk of death when considering patients for Xigris. Lilly is committed to ensuring that Xigris is used as safely and effectively as possible and to providing you with the most current product information. You can assist us with monitoring the safety of Xigris by reporting adverse events to the Lilly Answer Center at 1-800-LILLYRx ( 1-800-545-5979). Alternatively, adverse events may be reported to the FDA’s MedWatch reporting system (phone: 1-800-FDA-1088, facsimile: 1-800-FDA-0178, or website: www.fda.gov/medwatch). Enclosed is a copy of the prescribing information for Xigris that incorporates the change described above. Sincerely,
Paul Eisenberg, MD
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