FDA to examine use of anemia drugs for stroke

Federal health regulators said Friday that they were reviewing an experimental use of blockbuster anemia drugs made by Amgen Inc. and Johnson & Johnson that have been associated with higher death rates in a study involving stroke patients.

This month J&J; reported results from a German trial in which more stroke patients treated with its drug Eprex died than those taking a placebo. The study was designed to see whether the drug could improve cognitive function in patients who had suffered stroke, an unapproved use. The Food and Drug Administration has cleared the drugs only to boost red blood cell levels in patients with anemia.

Regulators posted a statement online saying they would work with manufacturers “to evaluate the risk and benefits associated with the investigational uses” of the drugs.

In the United States, J&J; sells Exprex under the name Procrit, and Amgen sells a version under the name Epogen.

An Amgen spokeswoman said Friday that the Thousand Oaks company was not conducting any trials of Epogen in stroke patients.

The FDA has bolstered warning labels on the drugs multiple times in the last two years to warn of risks of tumor growth and heart problems when the drugs are used at higher doses.

Regulators noted Friday that the doses used in the German study were higher than those on the drugs’ current labeling.