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

g treated with an aim to a cure and those receiving only palliative care.

Specifically, the plan requires that Amgen develop and disseminate a medication guide informing all cancer patients of the drugs' risks and that doctors not only discuss the risks with patients but also obtain patients' signatures.

Amgen is also obligated to ensure that all health-care providers prescribing and dispensing ESAs be trained and certified, and maintain active enrollment in the APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) program. Providers not enrolled in the program will not be able to prescribe ESAs to cancer patients and they must re-enroll every three years, Pazdur said.

Amgen will be required to provide progress reports on the program, which will then be reviewed by the FDA, said Dr. Patricia Keegan, director of CDER's Division of Biologic Oncology Products.

"We understand that the requirements of the safe use program will create new responsibilities for busy health-care providers and will require additional time for training, record keeping and other tasks, but we are not doing this to make things more difficult for health-care providers," Pazdur said. "We are doing this to make absolutely certain that patients are fully informed related to the use of these drugs before they begin treatment."

The new rules take effect in March, although providers will have a year to come up to speed.

These heavily promoted medicines have come under fire before. In 2007, the FDA added a black box warning to the drugs, which has been "updated several times as new studies and new information has been made available," Keegan said. The FDA also recommended that the medications be prescribed at the lowest doses possible because trials generally indicated an increased risk when blood levels were raised above 12 grams per deciliter.

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