FDA agrees plan requiring Amgen and J&J unit to educate doctors and patients on risks of anemia drugs
Under a plan reached with the US Food and Drug Administration, Amgen and a Johnson & Johnson subsidiary (Centocor Ortho Biotech) are required to document that cancer patients are briefed on the risks of anemia drugs before receiving them.
The FDA has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp (darbepoetin alfa), Epogen (epoetin alfa) and Procrit (epoetin alfa; co-marked by the J&J unit). The drugs, mostly used for chemotherapy and kidney dialysis patients, have seen a sharp decline in their sales after they were obliged to carry severe safety warnings regarding their ability to cause tumors.
Further 10%-15% sales drop anticipated
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