HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, September 27, 2008

F.D.A. Reviewing Deaths in Anemia Drug Study

The New York Times reports that federal health officials, on September 26, said that they were reviewing a higher rate of deaths among patients treated with a Johnson & Johnson anemia drug in a German study of stroke patients.  The New York Times writes,

EprexSixteen 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 Food and Drug Administration said in a statement.

The study was testing whether Eprex could improve brain function in stroke patients, an unapproved use of the drug.

The 522 patients were given relatively high doses of Eprex for three days or a placebo. Most were not anemic, the drug agency said.

Eprex is known generically as epoetin alfa. Johnson & Johnson also sells epoetin alfa under the name Procrit. Amgen sells a version under the name Epogen.

The blockbuster drugs are part of a class called erythropoiesis-stimulating agents, or ESAs, which are approved for treating patients with kidney disease and cancer.

The safety of ESAs came under scrutiny in recent years after other studies found tumor growth or shorter survival for some patients given high doses.

The drug agency ordered strong new warnings on the medicines in July.

The agency said Friday that it was aware of other trials testing the potential neurological effects of epoetin alfa.

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 agency said.

Johnson & Johnson reported last week that early data showed Eprex patients in the German study died more frequently than placebo patients, and said it was doing additional analyses to better understand the findings. The company alerted the drug agency to the findings, a Johnson & Johnson spokesman, Mark Wolfe, said Friday.

The study was initiated by the researcher, Mr. Wolfe said. Johnson & Johnson provided financing and supplies of the drug but was not involved in the trial’s design or conduct, he said.

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