FDA Announces new safety plan for anemia drugs
Washington, D.C – February 16, 2010
The Food and Drug Administration (FDA) released the final Risk Evaluation and Mitigation Strategy (REMS) for Erythropoetin Stimulating Agents (ESAs) marketed under the brand names Epogen, Procrit and Aranesp. The plan has been finalized and will be implemented within 45 days by the manufacturer.
Many cancer patients take ESAs or receive blood transfusions to reduce the effects of chemotherapy induced anemia. Recent studies have shown tumor growth or increased mortality in some cancers prompting numerous regulatory changes, including this REMS.
Patients will have to receive ESAs from a certified provider who has completed education about the drug and will discuss the risks and benefits of the drug. Patients will be required to sign a form confirming that they have had such a conversation, and potentially other forms as well.
The purpose of this program, according to the FDA, is to allow patients access to information that can help them make more informed choices. The goals of any patient’s treatment plan should be discussed with the patient’s doctor as the goals for a curative care plan may differ from that of a palliative plan. It is therefore important for patients receiving chemotherapy to weigh the risks and benefits carefully, in light of their individual treatment plan.
The REMS instituted is based on evidence that showed that “ESAs cause tumors to grow faster or resulted in earlier death for cancer patients,” states Richard Pazdur, M.D., Director, Office of Oncology Drug Products, CDER, FDA. Patients should consider the risks and benefits of any drugs, including ESAs.
Please talk to your provider if you have any questions or concerns about your use of ESAs.