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FDA Issues New Warnings for Drotrecogin alfa
Mar 22, 2005, 11:34, Reviewed by: Dr.
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This new warning, 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 drotrecogin alfa.
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By Akanksha, Pharmacology Correspondent,
Eli Lilly and Company (Lilly)and FDA has notified health professionals 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, 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 drotrecogin alfa.
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) allcause
mortality was numerically higher in the drotrecogin alfa 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 
- FDA
MEDWATCH
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 at its website).
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