Aranesp, Epogen and Procrit
April 14, 2017 – The U.S. FDA has rescinded the risk evaluation and mitigation strategy (REMS) for the erythropoiesis-stimulating agents (ESAs) Aranesp® (darbepoetin alfa – Amgen), Epogen® (epoetin alfa – Amgen), and Procrit® (epoetin alfa – Johnson &Johnson). Beginning in 2004, FDA requested labeling updates, physician communications and other regulatory changes after continuing reports of severe side effects from ESAs. Side effects may increase the risk of serious anemias, adverse cardiovascular events, worsened kidney disease and tumor progression or recurrence for some cancers types. In 2011, a REMS was implemented, requiring healthcare professionals who prescribe and hospitals that dispense ESAs for cancer patients to enroll in training under the APPRISE Oncology Program. It also requires that patients be counseled about risks and that both patients and prescribers sign forms acknowledging the risks prior to initiating ESA therapy. After analyzing more recent information, which includes usage patterns, FDA has withdrawn the REMS and discontinued the APPRISE Oncology Program.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.