The U.S. Food and Drug Administration on Thursday approved new “black box” warnings on labels of ESA – erythropoiesis-stimulating agents, which are drugs used to treat certain types of anemia.
The warnings cover the drugs Aranesp, Epogen and Procrit, and detail their dangers to patients with cancer and patients with chronic kidney failure. Those dangers include heart attack, stroke, heart failure and cancer tumor growth and shortened survival.
The drugs had been touted as a treatment to lessen fatigue and improve quality of life among cancer, HIV and other patients with anemia, but the new label says there’s no evidence to back that claim.
This is the fifth time the FDA has called for label changes for these drugs — also known as ESAs — since Procrit was approved in 1989
For cancer patients, the new warnings emphasize that the drugs can cause tumor growth and reduce survival among patients with advanced breast, head and neck, lymphoid and non-small cell lung tumors. This is especially true when the dose is designed to produce a hemoglobin level of 12 grams per deciliter of blood or more.
For hemoglobin levels less than 12 grams per deciliter, the label will say there is no evidence to determine if the drugs cause any of these problems
The new label will also make it clear that ESAs should be used in cancer patients only when their anemia is caused by chemotherapy and not from other causes. Also, ESAs should be stopped when the patient’s chemotherapy has ended.
For patients with chronic kidney failure, the new black box warning says that ESAs should be used to keep hemoglobin levels between 10 grams per deciliter to 12 grams per deciliter. Higher hemoglobin levels in these patients can increase the risk for death, stroke, heart attack or heart failure.
The FDA is working with Amgen on new clinical trails and is also reviewing a Medication Guide that will explain the use of these drugs to patients.
Epogen, Procrit and Aranesp are used to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in some cancer patients. Epogen and Procrit are also used in some anemic patients who are undergoing surgery to reduce the need for blood transfusions. These drugs are also used to treat anemia in HIV patients taking AZT.