WASHINGTON (Reuters) — Federal health officials said Friday 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.
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 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. Read more here……….
