The health care giant’s Ortho Biotech unit issued a statement last night saying it learned of preliminary data from a study in which patients were given its drug within six hours of suffering an ischemic stroke. The trial was designed to determine whether the med could help stroke patients.

In the study, which was designed and initiated by a German scientist, more patients treated with Eprex died than in the comparison group receiving a placebo. “Ortho Biotech chose to publicly communicate the results…because of what we feel are potential safety implications,” a J&J spokesman tells the Associated Press.

Procrit, which is sold as Exprex outside the US and also marketed as Epogen by Amgen, is approved for treating anemia in cancer patients, people with kidney disease undergoing dialysis and some patients with HIV. They are not approved in any country for treating ischemic stroke patients.

The study began in 2003 and Ortho Biotech provided the med and other funding, but it was designed by a professor at the Max Planck Institute for Experimental Medicine in Goettingen, Germany. The spokesman did not have further details, and the professor, Hannelore Ehrenreich, could not be reached.

Ortho Biotech has reported the information to European regulators and the FDA, and further analyses are being done to better understand the results. Ehrenreich, who plans to promptly publish the results, has previously published several studies on the topic, including a 2006 paper stating that the drug has limited stroke damage in rodent testing and that results from the first human testing are promising, but larger studies are needed, according to the AP.