FDA Reviews Experimental Use of Anemia Drugs

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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.



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