May 12, 2008

Why didn't FDA act on Procrit ads?

The Cancer Letter reports:

Internal FDA documents show that the agency made a series of unsuccessful attempts to stop a direct-to-consumer advertising campaign that claimed that Johnson & Johnson’s erythropoiesis-stimulating agent Procrit (epoetin alfa) improved “fatigue” associated with chemotherapy-induced anemia.

The advertising campaign, which is widely credited with making ESAs into the biggest-selling class of oncology drugs, was allowed to proceed with relatively minor changes after the FDA Office of Chief Counsel became involved in the controversy.

Posted by schwitz at May 12, 2008 08:52 AM | TrackBack
Comments

My Mother was prescribed a similar drug, Aranesp, by her oncologist for anemia even though she had finished chemo over four years earlier and had no signs of cancer. She died of a pulmonary embolism at age 70 within days of beginning the Aranesp, in Novemer 2006. I have since learned that use of ESA's by non-chemo patients is "off label" but was very common. Soon after her death, the news reports about the dangers of ESA's began. My family and I are all heart-broken over what we view as a needless death. I believe the FDA has dropped the ball.

Posted by: Penny at May 12, 2008 11:59 AM
The views and opinions expressed in this page are strictly those of the page author. The contents of this page have not been reviewed or approved by the University of Minnesota.