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Page: << Prev | 1 | 2 | 3 | Next >> The FDA will continue to look into the results of this study, Robie-Suh said. "We have asked for more information about the study. We would certainly like to receive the data, but those data are not in our hands or under our control," she said.
For the trial, 522 stroke patients were randomly assigned to receive relatively high doses of epoetin alfa or a placebo. Some patients were also given R-tPA, a powerful clot-busting drug.
Three months after the start of the trial, 16 percent of the patients who received high doses of the drug epoetin alfa died, compared with 9 percent of patients who were not given the drug, according to the U.S. Food and Drug Administration (FDA).
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Among the deaths in the German trial, about 50 percent occurred within the first week after the drug was started. Among those receiving the drug, 4 percent died from bleeding within the brain compared with 1 percent of the patients who were not given the drug.
The FDA said that it expects to receive more data on the study "within the next several weeks," and when the agency's analysis is complete, it will "communicate our conclusions and recommendations to the public."
Friday's FDA notice was issued after Ortho Biotech -- the division of the pharmaceutical giant Johnson and Johnson, which makes Procrit -- alerted the agency to the results of the German trial.
"Ortho Biotech has become aware of preliminary data from an investigator-initiated experimental study of the effects of Epoetin alfa in patients with acute ischemic stroke," the company said in a Sept. 17 statement. "Ortho Biotech has reported this information to the U.S. Food and Drug Administration and to European regulatory authorities. Additional analyses are under way to better understand these preliminary results."
"This study is interesting, because people were looking at potential neuroprotective effects of erythropoiesis-stimulating agents (ESAs)," said Dr. Samuel M. Silver, a spokesman for the American Society of Hematology.
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