FDA Issues New Warnings for Anemia Drugs

By Steven Reinberg
HealthDay Reporter
Friday, November 9, 2007; 12:00 AM

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THURSDAY, Nov. 8 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday approved new "black box" warnings on labels of erythropoiesis-stimulating agents, which are drugs used to treat certain types of anemia.

The warnings cover the drugs Aranesp, Epogen and Procrit, and detail their dangers to patients with cancer and patients with chronic kidney failure. Those dangers include heart attack, stroke, heart failure and cancer tumor growth and shortened survival.

The drugs had been touted as a treatment to lessen fatigue and improve quality of life among cancer, HIV and other patients with anemia, but the new label says there's no evidence to back that claim.

"Today's labeling changes are being made to make clear recommendations about the safe and effective use of these products and to strengthen the information about the risks that these drugs pose to patients with cancer and to patients with chromic kidney failure," Dr. Richard Pazdur, the FDA's director of the Office of Oncology Drug Products at the Center for Drug Evaluation and Research, said at a Thursday teleconference.

This is the fifth time the FDA has called for label changes for these drugs -- also known as ESAs -- since Procrit was approved in 1989, Pazdur said.

"We are emphasizing that ESAs should be used at the lowest dose necessary to avoid blood transfusions, since that is the only identifiable benefit for ESAs," Dr. John Jenkins, director of the FDA's Office of New Drugs. "Doctors should have discussions with their patients about whether to use ESAs at all."

These drugs are synthetic versions of a protein made in the kidney that tells bone marrow to produce red blood cells. The drugs are manufactured by Amgen Inc., of Thousand Oaks, Calif. Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, N.J., a subsidiary of Johnson & Johnson.

Dr. Roger M. Perlmutter, Amgen's executive vice president of research and development, said in a prepared statement that his company "has been working closely with the FDA and J&JPRD [Pharmaceutical Research and Development] to ensure that the information contained in the approved labeling for ESAs accurately reflects the current state of knowledge of these important products and to develop a comprehensive and feasible clinical study program to complement our existing pharmacovigilance program.