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FDA Reports New Risks Posed by Anemia Drugs
Date:1/3/2008

ells. The drugs are manufactured by Amgen, of Thousand Oaks, Calif. Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, N.J., a subsidiary of Johnson & Johnson.

For cancer patients, November's revised warnings emphasized 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 says there's no evidence to determine if the drugs cause any of these problems, the FDA said.

The revised label also made 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.

The revised label also said there's 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.

More information

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



SOURCES: Jan. 3, 2008, news release, U.S. Food and Drug Administration; Nov. 8, 2007, teleconference with Richard Pazdur, M.D., director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


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