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FDA Tightens Controls on Anemia Drugs
Date:2/16/2010

Procrit, similar medicines have been tied to strokes, tumor progression in cancer patients, agency says

TUESDAY, Feb. 16 (HealthDay News) -- U.S. federal health authorities on Tuesday rolled out a new safety plan for the use of Procrit and similar anemia drugs by people with cancer.

These medicines -- often used by cancer patients to lower the need for blood transfusions and improve quality of life -- have been tied to stroke, heart failure, tumor promotion and death in recent studies.

"The plan requires the drug manufacturer to implement a program to ensure that health-care professionals understand the appropriate use of these drugs and adequately inform patients of the drugs' risks," said Dr. Richard Pazdur, director of the Office of Oncology Drug Products at the Center for Drug Evaluation and Research (CDER), part of the U.S. Food and Drug Administration (FDA), at an afternoon news conference.

Procrit is one of three so-called erythropoiesis-stimulating agents (ESAs) manufactured by Amgen (the other two are Epogen and Aranesp), all of which are covered under the new plan. All three drugs are FDA-approved for people battling cancer, those infected with HIV, people with kidney failure and certain patients undergoing surgery, and all three carry with them an elevated risk of blood clots, stroke, heart failure, tumor promotion and death.

The new rules do not apply to indications other than use by cancer patients.

"Amgen will ensure that only certified health-care professionals may dispense and prescribe ESAs to patients with cancer and that all certified prescribers are trained to understand and communicate to patients the increased risk of tumor growth that these drugs present to patients with cancer," Pazdur said.

"The risks for cancer patients are much different," he added. Nor are the risks equal for all cancer patients, with the agency making a distinction between patients bein
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