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ESAs Pose Health Risks, FDA Warns

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The Associated Press

Published: November 9, 2007

WASHINGTON - The Food and Drug Administration called on physicians Thursday to warn cancer patients undergoing chemotherapy that certain anti-anemia drugs led to tumor growth and decreased survival in some patients.

At issue are drugs sold under the brand names Procrit, Epogen and Aranesp. These drugs are genetically engineered versions of a natural protein that increases the number of red blood cells.

The drugs generated $10 billion in sales last year.

The FDA said on Thursday it approved several labeling changes for the drugs, which are commonly referred to as ESAs. For patients with cancer, the new label emphasizes that the drugs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer.

The agency had approved new labels for the medicines in March. But the newest warning emphasizes the types of cancers affected, and it notes that the medicines did not improve the overall quality of life for patients.

The three drugs are manufactured by Amgen Inc. of Thousand Oaks, Calif. Procrit is marketed and distributed by a subsidiary of Johnson & Johnson.

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