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The U.S. Food and Drug Administration (FDA) is examining an increased rate of deaths in patients treated with an anemia drug made by Johnson & Johnson in German trials of stroke patients.
The study found 16 percent of patients treated with the drug, Eprex, within six hours of the onset of stroke symptoms died more frequently, compared with nine percent of patients who were given a placebo, federal health officials said in a recent statement.
The results have been reported to the FDA and European regulatory authorities. Additional research is in progress to better understand the preliminary findings.
Eprex, also known as Procrit or Epoetin Alfa, is a drug used to treat anemia. The drugs are part of a class called erythropoiesis-stimulating agents (ESAs), which are approved for treating patients with cancer and kidney disease.
In recent years, the safety of ESAs has come under fire after other studies have found tumor growth and shorter survival rates in some patients given high doses of the drug.
The agency is aware of other current ongoing trials testing the potential neurological effects of Eprex.
The increased death rates in the study “suggests close monitoring of patients in other ongoing trials to observe adverse outcomes and to determine whether or not the potential benefits outweigh the risks for enrolled patients is needed,” said the agency.
Last week, Johnson & Johnson reported that early data showed Eprex patients in the German study died more frequently than patients taking placebo’s and said they are doing additional analysis to better understand the findings.
The company supplied financing and drug supplies, but had no role in the design or conduct of the trial, according to Mark Wolfe, a Johnson & Johnson spokesman. #