FDA Orders for Safety-Related Labeling Changes Are Commendable (Rep. John Dingell)
Wednesday, August 6th, 2008I applaud FDA’s decision to make label changes to three Erythropoiesis-Stimulating Agents (ESAs) manufactured by Amgen. Beginning last year, a steady stream of negative ESA study findings prodded FDA to take a series of remedial actions to protect the American people from these dangerous drugs. FDA’s recent action ordering Amgen to include additional safety related information to the drug label is commendable.
Early last year, Rep. Stupak and I opened an investigation into the safety of ESAs after learning of alarming reports indicating that ESAs, when used at higher than recommended doses, appeared to increase blood clots, stimulate tumor growth, and produce significantly higher mortality rates than placebos. Last week, under new enforcement authority in the FDA Amendments Act of 2007, FDA ordered Amgen to make additional safety-related labeling changes for Aranesp, Epogen and Procrit — three drugs approved to reduce the need for blood transfusions in cancer and dialysis patients suffering from anemia.

