Early Warning About Increased Mortality in Epoetin Alfa Trial
Stroke treatment trial participants should be closely monitored for adverse outcomes
MONDAY, Sept. 29 (HealthDay News) -- The U.S. Food and Drug Administration has issued a warning to researchers conducting clinical trials of epoetin alfa in the treatment of stroke patients, after a German trial of the drug to treat acute ischemic stroke reported increased mortality among the study group versus controls.
The trial of 522 adults diagnosed with ischemic stroke in the area of the middle cerebral artery randomized patients to receive either 40,000 intravenous doses of epoetin alfa once a day for three days, or placebo, and over the following 90 days there was a 16 percent mortality rate in the treatment group, versus 9 percent for the placebo group, the FDA reports.
Although Eprex, the brand used in the study, is not marketed in the United States, it is in the same class of erythropoiesis-stimulating agents that are FDA-approved to treat anemia in certain patients. It is sold as Procrit, marketed by Johnson & Johnson of New Brunswick, N.J. and Epogen, marketed by Amgen Inc., of Thousand Oaks, Calif., according to the FDA statement. Epoetin alfa is undergoing other trials for potential neuroprotective effects in stroke patients, the FDA notice states.
"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," the FDA notes in a statement.