New FDA Warnings for Anemia Drugs
Drugs Known as ESAs Can Increase Risk of Tumor Growth and Death
March 9, 2007 -- Federal regulators announced new warnings for anemia drugs Friday following evidence that they can worsen cancer and increase the risk of death in some patients.
FDA officials say Aranesp, Epogen, and Procrit will now carry "black-box" warnings alerting patients and doctors to lessen the risk of blood clots by using the lowest dose of medication needed to avoid the need for blood transfusion. The new boxed warning also includes information that they can increase risk for death or serious medical complication if used too aggressively in some patients.
The agency is also telling researchers to consider ending clinical trials involving the drugs.
Aranesp, Epogen, and Procrit are in a class of drugs called erythropoiesis-stimulating agents (ESAs) used to stimulate the production of red blood cells. The drugs are widely used in patients with chronic kidney failure (such as those with end-stage renal disease who require dialysis) and patients undergoing cancer treatments.
"Recent reports of studies with erythropoiesis-stimulating agents (ESAs) have shown a higher chance of serious and life-threatening side effects and greater number of deaths in patients treated with these agents," an FDA public health advisory says.
Quality-of-Life Claims Questioned
The drugs are used to prevent the need for blood transfusions in kidney failure and cancer patients. But officials indicated that doctors have increasingly used ESAs to boost red blood cells higher than the level needed to avoid transfusion in an effort to prevent fatigue in patients.
Six studies showing increased risks when ESAs were used to boost red cell counts to the higher levels led to Friday’s warnings, the FDA says.
"The FDA reminds physicians that erythropoiesis-stimulating agents are approved for the reduction in red cell transfusion. For oncology patients these products have not been shown to improve or relieve symptoms of anemia or to improve quality of life," says Richard Pazdur, MD director of FDA’s office of oncology drug products.
Amgen Inc. sold $4.1 billion worth of Aranesp last year, making it one of the company’s top selling drugs.
Johnson & Johnson claimed Procrit can improve energy and quality of life in its direct-to-consumer advertisements, a claim the FDA now says it should no longer make.