FDA Approves REMS for Drugs That Combat Anemia

WASHINGTON -- The FDA has announced a formal strategy to reduce the risks of erythropoiesis-stimulating agents (ESAs) for cancer patients who take the drugs to treat anemia caused by chemotherapy. Beginning in March, the ESAs darbepoetin (Aranesp) and epoetin alfa (Epogen and Procrit) -- all made by Amgen -- will operate under a Risk Evaluation and Mitigation Strategy (REMS) that will require healthcare providers who prescribe the drugs for cancer patients to register with Amgen and enroll in a training program on use of the agents. The agency is requiring the REMS because studies have shown that ESA use can result in tumor growth and shorten survival in cancer patients who use them to combat anemia. ESAs have also been shown to increase the risk of MI, heart failure, stroke, and blood clots. Physicians who fail to enroll in Amgen's APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) program within a year will be barred from prescribing the drugs. The REMS also will require physicians to provide their cancer patients with a medication guide on how to safely use the drugs and will require doctors to discuss risks, benefits, indications, and dosing guidelines when prescribing ESAs to cancer patients. Patients will be required to sign a document indicating that they understand the risks. "We are doing this to make absolutely certain that patients are fully informed about the risks of these drugs before they begin treatment," said Richard Pazdur, the director of oncology drug products at the FDA, on a Tuesday press call. Use of the ESAs has been controversial. In 2007, CMS announced it would put limits on dose and duration of ESA therapy in reaction to an FDA decision to require a black box warning on the drugs. "We understand that the requirements of the safe use program will create new responsibilities for busy healthcare providers," Pazdur said. "It will require additional time for training, record-keeping, and other tasks related to complying with the program." "However, we are not doing this to make things more difficult for healthcare providers," he said. "We are doing this to make absolutely certain that patients are fully informed of the risks related to the use of these drugs before they begin treatment and throughout their treatment regimen." Hospitals and physicians that dispense ESAs to cancer patients can enroll in the APPRISE program by contacting Centocor Ortho Biotech Products or an Amgen field representative, according to a release from Centocor Ortho Biotech Products. ESAs, which stimulate bone marrow to make red blood cells, are often prescribed to cancer patients for chemotherapy-related anemia. The REMS does not apply to the drugs when they're used to treat kidney disease. The FDA has said it will hold an advisory panel meeting later this year to discuss using ESAs in that setting.