FYI - FDA Announces new safety plan for anemia drugs

Found this information today on FDA approval of new safety plan for drugs such as Epogen, Procrit and Aranesp.

Here is some of the info:

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.

Hope this info is useful

Jami