More Anemia Drugs to Undergo FDA Safety Review

Aranesp is not the only anemia drug to catch the ever more watchful eye of the FDA. Now, Procrit and Epogen will have to undergo another FDA safety review. It’s the fourth time since 2007 that these drugs have been reviewed for safety concerns. On Wednesday, the New England Journal of Medicine published a commentary by safety officials who noted “major concerns” with the drugs’ safety in treating those suffering from anemia as a result of chronic kidney disease.
Amgen, the manufacturer of both Epogen and Aranesp, has witnessed its sales slip since 2007 when the FDA began changing the labels due to safety concerns. Procrit is sold by Johnson & Johnson but manufactured by Amgen.
In its response to the comment in the New England Journal of Medicine, an Amgen official stated, ““highlighted areas of incomplete understanding”.