U.S. health officials have been reviewing a higher rate of deaths among patients treated with Eprex, a Johnson & Johnson anemia drug, in a German study of stroke patients. Sixteen percent of patients who were treated with Eprex died three months after the study began compared with 9% who took a placebo. The study was testing to find out if Eprex could improve brain function in stroke patients, which is an unapproved use of the drug. The 522 patients in the test, most of whom were not anemic, were given relatively high doses of Eprex for three days, or were given a placebo.
Eprex is known generically as epoetin alfa. Johnson & Johnson also sells epoetin alfa under the name Procrit. Amgen Inc. sells a version under the name Epogen. The blockbuster drugs are part of a class called erythropoiesis-stimulating agents (ESAs), which are approved for treating patients with kidney disease and cancer. In recent years, the safety of ESAs came under scrutiny after other studies found tumor growth or shorter survival for some patients given high doses. In July, the FDA ordered strong new warnings on the medicines.
According to the FDA, the higher death rate in the German 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.” The FDA says it expects to receive more data within the next several weeks and that the agency will announce its conclusions when the review is completed.
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