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2005 Safety Alert: Xigris [drotrecogin alfa (activated)]

Mar 17, 2005 | www.fda.gov

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.

WARNINGS

Mortality in Patients with Single Organ Dysfunction and Recent Surgery

Among the small number of patients enrolled in PROWESS with single organ dysfunction and recent surgery (surgery within 30 days prior to study treatment) all-cause mortality was numerically higher in the Xigris group (28-day: 10/49; in-hospital: 14/48) compared to the placebo group (28-day: 8/49; in-hospital: 8/47).

In a preliminary analysis of the subset of patients with single organ dysfunction and recent surgery from a separate, randomized, placebo-controlled study (ADDRESS) of septic patients at lower risk of death (APACHE II score <25 or single sepsis-induced organ failure at any APACHE II score) all-cause mortality was also higher in the Xigris group (28-day: 67/323; in-hospital: 76/325) compared to the placebo group (28-day: 44/313; in-hospital: 62/314).

Patients with single organ dysfunction and recent surgery may not be at high risk of death irrespective of APACHE II score and therefore may not be among the indicated population. Xigris should be used in these patients only after careful consideration of the risks and benefits.

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.

Sincerely,

Paul Eisenberg, MD
Vice President, Global Product Safety


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