J&J reports anemia drug linked to deaths in study

[okarol]

Wednesday, Sep. 17, 2008
J&J reports anemia drug linked to deaths in study
By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. A blockbuster anemia drug made by a Johnson & Johnson company has been linked to the deaths of some patients in an experiment testing whether it could help stroke patients.

J&J's Ortho Biotech unit said late Wednesday that it had learned of preliminary data from a study in which participants were being given its drug Procrit within six hours of suffering an ischemic stroke, in which an artery blockage limits the flow of blood and oxygen to the brain.

In the study, which was designed and initiated by a German scientist, more patients treated with Procrit died than the comparison group receiving a placebo.

"Ortho Biotech chose to publicly communicate the results ... because of what we feel are potential safety implications," said company spokesman Mark Wolfe.

He said it is J&J's understanding that the idea behind the study "was based on data suggesting that patients suffering from stroke might benefit from epoetin therapy."

Epoetin alfa is the chemical name for the Procrit brand. The drug is also sold by another Johnson & Johnson unit under the name Eprex outside the United States, and Amgen Inc. sells it under the name Epogen in this country.

The drugs are all 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.

Strong warnings have been added to the package information for these drugs in recent years, as they have been linked to growth of existing tumors in some cancer patients and, at high doses, to heart complications and death.

The drugs work by stimulating production of the oxygen-carrying red blood cells, and they have been linked to doping by some athletes.

Wolfe said the study began in 2003 and that Ortho Biotech provided the medication used in the study and other funding. It was designed by a professor at the Max Planck Institute for Experimental Medicine in Goettingen, Germany, he said. He did not have further details, and the professor could not be reached immediately.

According to Wolfe, the study had been completed and preliminary data revealed a higher death rate.

Ortho Biotech has reported the information to European regulators and the U.S. Food and Drug Administration, and further analyses are being done to better understand the results.

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