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Deaths Increase with Procrit in Stroke Study
Regulators Warned
Preliminary results from a study of the effects of Epoetin alfa in patients with acute ischemic stroke have shown that patients treated within 6 hours after the onset of a stroke died more frequently than patients given placebo.Ortho Biotech became aware of preliminary data from an investigator-initiated experimental European study. They have reported the results to both the U.S. Food and Drug Administration and to European regulatory authorities.
Johnson and Johnson's anemia drug, Epoetin, is marketed as EPREX® / ERYPO® outside the U.S. by Janssen-Cilag, as PROCRIT® in the U.S. by Ortho Biotech and as EPOGEN® in the U.S. by Amgen.
SEPT-18-08: Procrit linked to deaths in stroke trial [FIERCE PHARMA: PROCRIT LINKED TO DEATH]
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