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Warnings on anemia drugs strengthened

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Associated Press / November 9, 2007

WASHINGTON - Amgen Inc. and Johnson & Johnson have strengthened warnings about the risks, including death and stroke, associated with their blockbuster anemia drugs.

While sales of the drugs have suffered since the Food and Drug Administration raised safety concerns this year, analysts said yesterday's action could provide some relief, since the labeling is not as restrictive as it could have been.

The new labeling applies to Amgen's Epogen and Aranesp and J&'s Procrit, which are used to treat the blood disorder anemia in kidney-failure and chemotherapy patients.

A new boxed warning label, the most serious a drug can carry, emphasizes that cancer patients had increased risk of death and showed accelerated tumor growth when treated with elevated doses of the drug.

In March, FDA approved a less serious warning that described studies that showed the risks.

FDA said it is still unclear whether cancer patients face the same risks even when using normal doses of the drugs.

At the FDA's request, the companies also strengthened a warning that using the drugs in higher doses can increase risk of heart attack, stroke, and death in kidney failure patients. The label cautions physicians that using higher-than-recommended doses of the drugs does not benefit patients.

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