FDA Requires Doctors to Advise Patients about ESA Risks and Benefits | Anemia in the News | NAAC National Anemia Action Council (U.S.)

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FDA Requires Doctors to Advise Patients about ESA Risks and Benefits
Updated: February 18, 2010

The U.S. Food and Drug Administration (FDA) announced that they will soon require medical professionals prescribing erythropoiesis-stimulating agents (ESAs) to provide a Medication Guide to patients and to formally educate them about the drug’s risks and benefits.

The FDA will be implementing their new standards as part of a risk evaluation and mitigation strategy (REMS) intended to support informed decisions between patients and professionals, and mitigate the risks associated with the use of anemia drugs. As part of a the new standards, oncologists and professionals prescribing ESAs to treat anemic cancer patients will also be required to enroll in the ESA APPRISE Oncology program and complete a training module.
What Else Do You Need to Know?

Read more about these regulations in the feature article New Rules and APPRISE Program Regulate ESA Use in Oncology.


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