Anemia in the News

The FDA has reported that early data from a clinical trial in Germany investigating the use of epoetin alfa treatment in patients with ischemic stroke showed excess 90-day mortality. Preliminary safety findings in the 522-patient trial revealed that 16% of those treated with epoetin alfa died within 90 days of the start of treatment compared with 9% in the placebo group. About half of the deaths in both groups occurred within the first seven days of treatment.

The investigational study at the Max Plank Institute for Experimental Medicine in Germany explored the potential for neuroprotective effects of the drug Eprex. The study tested its effectiveness to improve brain function of patients after stroke and improve their ability to take care of themselves.

Eprex is from a class of erythropoiesis-stimulating agents (ESAs) which are used to treat anemia in certain patients with cancer, kidney disease and HIV. Although the anemia drug Eprex is not marketed in the United States, the Food and Drug Administration (FDA) is analyzing data from this study and evaluating the relationship between the ESAs and this emerging safety issue.

The FDA has officially stated they:

• DO NOT advise healthcare professionals to discontinue prescribing ESAs
• Anticipate the receipt of additional data within the next several weeks
• Are considering whether this new information warrants any regulatory action
• Will continue to communicate any conclusions or recommendations to the public

Please read more specifics in the announcement from the FDA or in the press release from the manufacturer, Ortho Biotech.

Last Updated: October 1, 2008