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FDA Questions Deaths in Anemia Drug Study

Federal health officials said that they were reviewing a higher rate of deaths among patients treated with a Johnson & Johnson anemia drug in a study of stroke patients. Sixteen percent of patients who were treated with the drug, Eprex, had died three months after the study began, compared with 9 percent who were given a placebo, the FDA said in a statement. The study was testing whether Eprex could improve brain function in stoke patients which is an unapproved use of the drug. Expex is known generically as epoetin alfa, which is also known as Procrit. The drugs are part of a class called ESAs which are approved for treating patients with kidney disease and cancer. The safety of ESAs came under scrutiny after studies found tumor growth or shorter survival for some patients given high doses. The higher death rate in the study “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. To read the full story, click here.