Important information about counterfeit EPOGEN

5/21/2002

Amgen, in cooperation with the FDA, notified pharmacists and health care providers of counterfeit EPOGEN (epoetin alfa). Epogen is used to treat the anemia that some patients with HIV/AIDS experience while taking zidovudine, commonly called AZT.

EPOGEN 40,000 U/mL vials in ten-pack boxes, lot number P002970 expiration date: 7/03 has been found to contain active ingredient that is approximately 20 times lower than would be expected for EPOGEN in 40,000 U/mL vials. Pharmacists and health care providers should carefully examine all vials of EPOGEN before use. A brief description and pictures of the differences between the actual product and the counterfeit are provided.

For more information, read the MedWatch 2002 Safety Summary, including photos and a link to the " Dear Healthcare Professional" letter, at:
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#epogen

Richard Klein
Office of Special Health Issues
Food and Drug Administration