J&J's epoetin-alfa linked to deaths in stroke trial

21 September 2008

US health care major Johnson & Johnson's blockbuster anemia drug epoetin alfa has been linked to patient deaths in a trial were it is being tested for stroke. Sold by J&J as Eprex/Erypro outside the USA and by Amgen as Procrit/Epogen in the USA, the agent is a member of the class of erythropoiesis-stimulating agents. The stroke study was designed and conducted by an investigator in Europe. J&J's Ortho Biotech unit provided the drug and funding, but the firm stressed that it had no role in designing or conducting the study. In the trial, patients suffering acute ischemic stroke who were treated with epoetin alfa within six hours of the onset of stroke symptoms died more frequently than subjects receiving placebo. Ortho Biotech has reported this information to US and European regulators. Additional analyses are underway to better understand these preliminary results, the firm noted.

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