FDA Aranesp, Epogen and Procrit Side Effects Warning

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals of new safety information for
erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa),
Epogen (epoetin alfa), and Procrit (epoetin alfa). Four new studies in
patients with cancer found a higher chance of serious and
life-threatening side effects or death with the use of ESAs. These
research studies were evaluating an unapproved dosing regimen, a patient
population for which ESAs are not approved, or a new unapproved ESA. FDA
believes these new concerns apply to all ESAs and is re-evaluating how
to safely use this product class. FDA and Amgen, the manufacturer of
Aranesp, Epogen and Procrit, have changed the full prescribing
information for these drugs to include a new boxed warning, updated
warnings, and a change to the dosage and administration sections for all
ESAs.