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FDA Issues New Warnings for Anemia Drugs

THURSDAY Nov. 8, 2007 -- 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.

"In the current label revisions, we have endeavored to include as much information as possible so physicians and their patients can make informed treatment decisions," he added.

For cancer patients, the new warnings emphasize that the drugs can cause tumor growth and reduce survival among patients with advanced breast, head and neck, lymphoid and non-small cell lung tumors. This is especially true when the dose is designed to produce a hemoglobin level of 12 grams per deciliter of blood or more.

For hemoglobin levels less than 12 grams per deciliter, the label will say there is no evidence to determine if the drugs cause any of these problems, the FDA said.

"We recommend that prescribers talk to their patients about the risks that ESAs might cause cancer to grow or shorten survival before they prescribe these drugs or continue ESA therapy, Pazdur said. "The risks should be weighed against blood transfusions and their associated risks."

The new label will also make it clear that ESAs should be used in cancer patients only when their anemia is caused by chemotherapy and not from other causes. Also, ESAs should be stopped when the patient's chemotherapy has ended, the FDA said.

For patients with chronic kidney failure, the new black box warning says that ESAs should be used to keep hemoglobin levels between 10 grams per deciliter to 12 grams per deciliter. Higher hemoglobin levels in these patients can increase the risk for death, stroke, heart attack or heart failure, the FDA said.

The new labeling also gives instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment.

The new label also says there is no evidence that ESAs improve symptoms of anemia, quality of life, fatigue, or patient well-being in cancer patients or patients with HIV taking the drug AZT.

"There are no data from controlled trials demonstrating that ESAs improve symptoms of anemia, quality of life, fatigue or patient well-being," Pazdur said.

The FDA is working with Amgen on new clinical trails and is also reviewing a Medication Guide that will explain the use of these drugs to patients, Pazdur said.

Epogen, Procrit and Aranesp are used to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in some cancer patients. Epogen and Procrit are also used in some anemic patients who are undergoing surgery to reduce the need for blood transfusions. These drugs are also used to treat anemia in HIV patients taking AZT.

More information

For more information on ESAs, visit the U.S. Food and Drug Administration.

Posted: November 2007


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