February 19, 2010

FDA unveils risk-management plan for Amgen anti-anemia drugs

By Kelley Luckstein

Physicians who want to prescribe Amgen Inc.'s anti-anemia drugs for cancer patients will have to register and undergo special training under a risk-management plan unveiled Tuesday by the Food and Drug Administration. Amgen also will require physicians to collect signed statements from patients attesting that they have been informed about the dangers of the drugs…


The drugs form a class called Erythropoiesis-Stimulating Agents and work by stimulating bone marrow to make red blood cells. Beyond safety issues, ESAs have repeatedly come under scrutiny by congressional overseers after concerns about overprescription of the drugs. They are among the costliest drugs paid for by Medicare, a fact that may have given regulators added incentive to focus on safety, said Ruben Mesa, a hematologist at the Mayo Clinic in Scottsdale, Ariz.


LA Times, by Andrew Zajac, 2/17/2010

Tags: anti-anemia drugs, Hematology

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