Safety Alerts & Recalls

What does this mean?

If you are receiving treatment with any of the Erythropoiesis-Stimulating Agents (EPOGEN, PROCRIT, or ARANESP), this new risk management program will help you and your doctor make informed decisions about the use of these medications.

Patients with cancer using ESAs should understand the risks associated with use of ESAs. These risks include: 1) ESAs in patients with cancer may cause tumors to grow faster, 2) ESAs may cause some cancer patients to die sooner, and 3) ESAs may cause some cancer patients to develop blood clots, and serious heart problems such as a heart attack, heart failure or stroke. Patients with cancer who are just starting a course of treatment with an ESA will be asked to sign a form that says you have talked with your healthcare provider about the risks of ESAs.

Patients with chronic kidney failure (includes patients on dialysis and those not on dialysis) using ESAs should understand the risks associated with use of ESAs, including the risk for stroke, heart attack, heart failure, blood clots, and death.

For all patients receiving an ESA, your healthcare provider will provide you with a Medication Guide when you receive a dose of EPOGEN, PROCRIT, or ARANESP. Read the Medication Guide to understand the benefits and risks of using an ESA and talk with your healthcare provider about any questions you may have about using ESAs. Regular blood tests while using ESAs will help guide the course of treatment and lower the risks of using these drugs. Your healthcare provider will tell you how often you should have blood tests.

If you have any questions about this new risk management program for EPOGEN, PROCRIT, and ARANESP, please follow up with your healthcare provider.

The FDA Requires a Risk Management Program for Erythropoiesis-Stimulating Agents (ESAs)

The FDA is requiring all drugs called Erythropoiesis-Stimulating Agents (ESAs) to be prescribed and used under a risk management program, known 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 EPOGEN, PROCRIT, and ARANESP. The FDA required the manufacturers of these products to 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 attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions.

As part of the REMS, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving EPOGEN, PROCRIT, or ARANESP. In addition to the Medication Guide, the ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) Oncology program will provide special training to healthcare professionals about the use of ESAs in patients with cancer.

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-02-16
Last Updated: 2010-02-17

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