Another potential safety problem for anemia drugs: Johnson & Johnson announced that Procrit was linked to the deaths of some patients in a stroke study. Participants in the European trial were given Procrit (Eprex in Europe) or placebo within six hours of an ischemic stroke, on the theory that anemia drugs might help stroke patients recover. But according to preliminary study data, more patients in the Procrit group died.
J&J says it has reported the data to European regulators and the FDA, and that it's further analyzing the data. The German scientist who designed the study said he plans to publish the results "promptly."
As you know, Procrit is one of the epoetin alfa drugs that's been dogged by safety concerns for about a year now. Strong warnings of heart complications and tumor growth--especially at high doses--have been added to the drugs' labels. The FDA has also limited their use, ruling out the treatment for cancer patients who might be cured, and for patients with certain types of cancer.
So why test it in stroke patients? The German study leader had done previous research that yielded a more positive result. We'll see how the data analysis goes.
- check out Ortho Biotech's release
- read the story in the Washington Times