FDA issues new safety requirements for anti-anemia cancer drugs

WASHINGTON -- Physicians who want to prescribe Amgen Inc.'s anti-anemia drugs for cancer patients will have to register and undergo special training or risk losing access to the drugs, under a long-awaited risk-management plan unveiled Tuesday by the Food and Drug Administration.

The company will also require physicians to collect signed statements from patients attesting that they have been informed about the dangers of the drugs, which can cause tumors to grow faster and have shortened the lives of some cancer patients, studies show. They may also increase risk of heart failure, blood clots and stroke.

The risk management plan had been under discussion since April 2008, after the studies of adverse effects had begun to raise concern.

The drugs, trade-named Epogen, Aranesp and Procrit, are widely used by dialysis patients and in other medical settings, but the safety plan applies only to use with cancer patients.

Two of the drugs, Epogen and Aranesp, are manufactured and sold by Amgen, of Thousand Oaks, Calif. The company also manufactures Procrit, which is marketed by Johnson and Johnson.

Physicians can begin registering for the safety program on March 24. Those who fail to sign up and take a 10- to 15-minute online training course within a year will lose prescribing privileges for the drugs.

The drugs are Erythropoiesis-Stimulating Agents, or ESAs, and work by stimulating bone marrow to make red blood cells.

Beyond safety issues, ESAs have come under scrutiny by congressional overseers because of alleged overuse by healthcare providers.

They are among the costliest drugs paid for by Medicare and that may have given regulators added incentive to focus on safety, said Dr. Ruben Mesa of the Mayo Clinic.