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Epoetin alfa (Eprex) in the Treatment of Acute Ischemic Stroke

September 30, 2008

The FDA informed healthcare professionals of preliminary results in an experimental German trial evaluating the efficacy of epoetin alfa in improving functional outcomes in acute ischemic stroke.  Treatment doses of epoetin alfa were higher than the usual doses recommended for anemia and recombinant tissue plasminogen activator (R-tPA) was used as needed.  Preliminary data showed a higher death rate in the epoetin alfa group (16%) compared to placebo (9%).  Approximately 50% of these patients died within the first 7 days of treatment.   Intracranial hemorrhage was noted as the cause of death in 4% of epoetin alfa patients and 1% of placebo patients. 

The FDA is recommending careful monitoring of the patients involved in ischemic stroke trials using epoetin alfa.  Further information should be forthcoming in the next several weeks.  Healthcare practitioners are urged to report all side effects of this nature to the MedWatch Reporting System.

Additional information is available at the following links:

• MedWatch Alert
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm110248.htm
• Early Communication about an Ongoing Safety Review
  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm136211.htm
• MedWatch Reporting System:
  http://www.fda.gov/medwatch/getforms.htm

Updated
September 30, 2008; University of Utah, Drug Information Service. Copyright 2008, Drug Information Service, University of Utah, Salt Lake City, UT.