FDA Tightens Warnings on Anemia Drugs

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"Moreover, ESAs administered to cancer patients increased mortality to cancer patients not receiving chemotherapy or radiation therapy when administered to target a hemoglobin of 12 grams per deciliter," Pazdur said. "ESAs are not indicated for this population," he said.

The FDA and the drugs' manufacturer, Amgen, have agreed to alter the product labeling to include a new black-boxed warning, and make changes in dosing instructions.

Amgen, based in Thousand Oaks, Calif., said it is cooperating with the FDA on the label change.

"Patient safety is unquestionably our top priority," Dr. Roger M. Perlmutter, executive vice president of research and development at the company, said in a prepared statement. "Amgen is committed to providing timely and appropriate communications to physicians and patients whenever we become aware of new safety information that could affect clinical practice."

Beyond the use of ESAs to prevent blood transfusions, the drugs have been advertised as a way for cancer patients to feel better during treatment. However, Pazdur said there is no evidence to back up this claim.

"For oncology patients, these products have not been shown to improve or relieve the symptoms of anemia, or to improve the quality of life in patients with cancer," Pazdur said. "The FDA is currently reviewing all quality-of-life claims in the product label. The FDA believes these quality-of-life claims should be consistent with current FDA standards."

More information

For more information on ESAs, visit the U.S. Food and Drug Administration.