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Procrit and Epogen Subject of FDA Safety Review Following Deaths in German Study | cialis online

Procrit and Epogen Subject of FDA Safety Review Following Deaths in German Study

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The Food & Drug Administration (FDA) says it is reviewing the safety of Procrit and Epogen after another brand of epoetin alfa was associated with higher death rates among patients in a German stroke study. Procrit and Epogen are known as erythropoiesis-stimulating agent (ESA) and are approved in the U.S. to treat anemia in cancer patients undergoing chemotherapy. They are made by Amgen, but Procrit is sold by Johnson & Johnson subsidiary Ortho Biotech under a licensing agreement.

The German study involved a version of epoetin alfa called Eprex, made by Johnson & Johnson, which is not marketed in the U.S. According to the FDA, Johnson & Johnson  made it aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke.  Treatment of anemia was not a goal of the trial and most patients were not anemic.

Over a period of ninety days after the start of the trial, 16 percent of the patients who received epoetin alfa died, compared to only 9 percent of patients in the placebo group.  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 epoetin alfa patients compared to 1 percent of patients in the placebo group.

According to the FDA, other clinical trials are investigating the use of epoetin alfa to improve the functional outcomes of patients after stroke.  The agency said that in light of the Germain trial, patients enrolled in those trials must be monitored closely adverse outcomes.  They should also be evaluated to determine if their potential benefits for enrolled patients outweigh the risks in these trials.

The FDA said it will be receiving more data about the German epoetin alfa trial in the next several weeks.  Once that data has been analyzed, the FDA will communicate its conclusions and recommendations regarding this drug to the public.

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