September 30, 2008 – The FDA said preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke show the drug may cause death.
The clinical trial utilized doses of epoetin alfa considerably higher than doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product. Over a period of 90 days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16 vs. versus 9 percent). Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4 percent of patients who received epoetin alfa compared to 1 percent of patients in the placebo group.
FDA anticipates the receipt of additional data within the next several weeks. As soon as the review of these data is complete, FDA will communicate its conclusions and recommendations to the public. The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.
For more information: www.fda.gov/medwatch/safety/2008/safety08.htm#ESA3