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U.S. Department of Health and Human Services

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

Audience: Oncological and nephrological healthcare professionals and patients

[Posted 02/16/2010] FDA and Amgen notified healthcare professionals and patients that all ESAs must be used under a REMS risk management program. As part of the risk management program, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving an ESA. Under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer. Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program. FDA is requiring a REMS 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 attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions.

[02/16/2010 - Drug Safety Communication - FDA]
[01/2010 - Epogen Prescribing Information - Amgen]
[01/2010 - Aranesp (darbepoetin alfa) Prescribing Information - Amgen]

Previous MedWatch alerts:

[07/31/2008]