Three very popular anemia drugs have had “black box” warning labels added to them by the FDA. Procrit, Epogen, and Aransep are usually given to cancer and kidney patients. Patients that take them have a higher risk of death or life-threatening side effects though.
The new boxed warning states that Erythropoiesis-stimulating agents (ESAs) increased the risk of death and serious cardiovascular problems when given at higher than recommended doses. The FDA also suggested that higher doses of the dangerous drug could lead to blood clots.
Director of the FDA’s Center for Drug Evaluation and Research, Steven Galson said “The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent clinical studies. The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the Oncologic Drugs Advisory Committee (ODAC) meets in May and further revisions to the labeling may occur after that meeting.”
The FDA advises doctors to use the drugs at the lowest possible level on their patients. If you are taking any of these drugs, please contact your doctor for more information.