FDA Looking Into Link Between Anemia Drug and Deaths
The U.S. Food and Drug Administration is investigating whether a Johnson & Johnson anemia drug increases the chance of death in stroke patients.
A German medical study found that 16 percent of stroke patients treated with the drug, Eprex, died within three months of taking the drug, compared to just nine percent who died after receiving a placebo. The study was designed to test whether Eprex might improve brain function in stroke patients, which is an unapproved use of the drug. Patients in the study were given relatively high doses of Eprex for three days and most were not anemic, the FDA said.
Eprex (generic epoetin alfa) is also sold by Johnson & Johnson under the name Procrit. Amgen Inc. sells the drug under the brand name Epogen.
After German researchers alerted the FDA about the deaths in their study, the FDA said it was reviewing the study’s findings.
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According to Boston Globe that "The FDA ordered changes July 30 to prescribing information for Procrit and Amgen's Aranesp after studies found safety risks in cancer patients. Procrit is identical to Epogen, Amgen's anemia medicine for kidney patients, and is sold by J&J under a licensing agreement."