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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 being 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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