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FDA Panel Wants Anemia Drug Warnings

Experts Concerned Drugs Are Overprescribed Despite Risks
WebMD Health News
Reviewed by Louise Chang, MD

May 10, 2007 -- An expert panel on Thursday urged the FDA to further rein in doctors' use of drugs that stimulate red blood cells because of mounting evidence that the medications cause some patients to die early.

The experts called for new warnings on anemia drugs used to boost production of red blood cells. The move comes only weeks after the agency warned the public that the drugs may speed cancer growth and spur heart attacks and other cardiovascular problems.

The drugs were approved because of their ability to lower the need for blood transfusions in cancer patients who have anemia (low red blood cell count) due to chemotherapy. But clinics and hospitals have seen an explosion in use of these drugs that FDA scientists and cancer experts say has gone beyond the state of scientific knowledge.

Experts Thursday complained that aggressive industry marketing to doctors and patients has prompted overuse of the drugs and may be contributing to safety problems.

In March, the FDA placed "black box" warnings on the three drugs available in the U.S.: Epogen, Procrit, and Aranesp. The warnings alert patients and doctors to lessen the risk of blood clots by using the lowest dose of medication needed to avoid the need for blood transfusion.

The boxed warning also includes information that the drugs can increase the risk of death or serious medical complication such as heart attacks and strokes if used too aggressively in some patients.

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