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FDA reviews experimental use of anemia drugs
2008-09-26
WASHINGTON - Federal health regulators said Friday they are reviewing an experimental use of blockbuster anemia drugs made by Amgen and Johnson & Johnson that has been associated with higher death rates in a study involving stroke patients. Earlier this month, J&J reported results from a German trial in which more stroke patients treated with its drug Eprex died than those taking a placebo. The study was designed to see whether the drug could improve cognitive function in patients who had suffered stroke, an unapproved use. The FDA has only cleared the drugs to boost red blood cell levels in patients with anemia, a blood disorder that causes fatigue. Regulators posted a statement online saying they will work with manufacturers "to evaluate the risk and benefits associated with the investigational uses" of the drugs. In the United States, J&J sells Exprex under the name Procrit, and Amgen Inc. sells a version under the name Epogen. An Amgen spokeswoman said Friday the Thousand Oaks, Calif.-based company is not conducting any trials of Epogen in stroke patients. FDA has bolstered warning labels on the drugs multiple times in the past two years to warn of risks of tumor growth and heart problems when the drugs are used at higher doses. Regulators noted Friday that the doses used in the German study were higher than those on the drugs' current labeling. The agency said it expects to receive more data on the trial in coming weeks and will make recommendations to doctors and patients after it completes its review. Shares of Amgen Inc. rose 62 cents Friday morning to $60.55, while Johnson and Johnson fell 24 cents to $69.60.
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