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Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp

Posted Feb 16 2010 3:29pm

The FDA is requiring all drugs called Erythropoiesis-Stimulating Agents (ESAs) to be prescribed and used under a risk management programknown as a risk evaluation and mitigation strategy (REMS)to ensure the safe use of these drugs. The ESAs that are part of the REMS are marketed under the names EpogenProcritand Aranesp. FDA required Amgenthe manufacturer of these productsto develop a risk management program because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attackheart failurestroke or blood clots in patients who use these drugs for other conditions.

ESAs work by stimulating the bone marrow to produce red blood cells. ESAs are approved for the treatment of anemia (low red blood cells) resulting from chronic kidney failurechemotherapycertain treatments for Human Immunodeficiency Virus (HIV)and also to reduce the number of blood transfusions during and after certain major surgeries.

As part of the REMSa Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs. In addition to the Medication GuideAmgen was required to develop the ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) Oncology program for healthcare professionals who prescribe ESAs to patients with cancer.

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