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FDA Awaits Data from a Study Linking Epoetin with Higher Mortality in Stroke Patients
In a preliminary communication on Friday, the FDA said that epoetin alfa — approved to treat anemia — may carry heightened mortality risk when used to improve functional outcomes in stroke patients. (The particular brand of epoetin in question, Eprex, is not currently marketed in the U.S.)
In a clinical trial conducted in Germany, patients with acute ischemic stroke who received intravenous Eprex (40,000 units daily for 3 days) were more likely to die within 90 days than were those on placebo (16% vs. 9%). In particular, death from intracranial hemorrhage occurred in 4% of Eprex recipients and 1% of placebo recipients.
The FDA noted that the dose used was "considerably higher" than the epoetin doses approved for the treatment of anemia.
The agency is expecting additional data within a few weeks, and after reviewing the data, will announce its conclusions to the public.
LINK(S):
FDA's preliminary communication (Free)
Associated Press story (Free)
Physician's First Watch coverage of labeling changes for epoetin alfa (Free)
Published in Physician's First Watch September 29, 2008
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