FDA Adds Black Box Safety Warning to EPO Drugs
Amgen announced today that US regulators added black box warnings to its erythropoietin drugs, Epogen and Aranesp. Similar warnings were also added to Johnson and Johnson’s Procrit which is licensed from Amgen. For those of you who don’t know, getting a black box warning on a drug label is like getting the “kiss of death” from a marketing and sales perspective. It certainly will not help sales of these products!
The new warnings approved by the Food and Drug Administration warn that the company's drugs increased death and accelerated tumor growth in patients with several types of cancer, including breast and cervical. Prior labeling warned of similar risks in other types of cancers.
The actions taken by the agency were not unexpected but suffice it to say there are a lot of unhappy Amgen and Johnson & Johnson employees in a Thousand Oaks, CA and New Brunswick, NJ
Until next time….
Good Luck and Good Job Hunting!!!!!!!
The FDA 
