Anemia Drugs Linked to Stroke Study Deaths: FDA

Sept. 27 -- FRIDAY, Sept. 26 (HealthDay News) -- Preliminary results from a German study suggest that stroke patients' use of anti-anemia drugs such as Aranesp, Procrit and Epogen might end up boosting their risk for death, the U.S. Food and Drug Administration (FDA) warned on Friday.

The goal of the study was to see if high doses of the anti-anemia drug epoetin alfa could improve the ability of stroke patients to take care of themselves after recovering from a stroke.

The hope was that the drug would be neuroprotective, but use of epoetin alfa now appears linked to a near-doubling of mortality.

This is not the first time that these drugs have come under scrutiny. In the United States, medications like Procrit were marketed heavily as anemia treatments, particularly for cancer patients and those with kidney failure.

However, in July of this year, the FDA called on manufacturers of Aranesp and Procrit to add a warning label that could limit their use for cancer patients.

These changes were spurred by studies that showed these types of medications might cause tumors to spread and also raise patients' risks for bleeding. These findings resulted in an FDA advisory committee recommending in June that while the drugs should remain on the market, they should not be used in patients whose cancer is curable.

The committee also voted to recommend against the drugs' use in patients with breast or head and neck cancer.

The new German study looked at the use of epoetin alfa as an aid to stroke recovery.

"These drugs are not licensed in the United States for this particular use," noted Dr. Kathy Robie-Suh, a team leader in the division of medical imaging and hematology at the Center for Drug Evaluation and Research, part of the FDA's Office of New Drugs and Office of Drug Safety.

"The drug has been approved for about 19 years for treating anemia in patients with acute renal [kidney] failure and in other settings," Robie-Suh said. "Today's warning doesn't have any bearing on the particular label uses of the product in the United States," she said.