Anemia Drugs to Carry Warning

Amgen's Aranesp and Epogen and J&J's Procrit will have black boxes.
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The Food and Drug Administration on Friday issued a health advisory for anemia drugs made by

Amgen

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and

Johnson & Johnson

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, warning that certain patients could suffer a greater risk of death, blood clots, strokes and heart attacks if they receive a higher-than-recommended dose.

The FDA's warning affects Amgen's Aranesp and Epogen and J&J's Procrit. Each drug is an erythropoiesis-stimulating agent, or ESA, a genetically engineered version of a natural protein made by the kidney. The protein, erythropoietin, increases the number of red blood cells.

"The agency is in the process of re-evaluating the safety of Aranesp, Epogen and Procrit on the basis of the results of recent clinical studies," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. "The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action."

A panel of outside medical advisers will discuss these drugs in May. "Further revisions to the labeling may occur after that meeting," Galson said. Labels were revised in 1997, 2004 and 2005, the FDA said. The FDA also issued health advisories in November 2006 and last month.

The agency said the companies are placing a "black box" warning on the drugs -- the FDA's strongest alert -- telling doctors to monitor patients' red blood cell levels and to adjust the drug dosage to avoid the need for blood transfusions.

Shares of Amgen recently dropped $1.90, or 3.1%, to $60.27. Aranesp, whose 2006 sales were $4.1 billion, and Epogen, which contributed $2.5 billion, accounted for 46% of Amgen's revenue last year.

J&J rose 39 cents, or 0.6%, to $62.11. Procrit's sales of $3.2 billion accounted for 6% of J&J's revenue last year. Procrit and Epogen are the same. J&J sells Procrit under license from Amgen.

The ESA drugs are approved to treat anemia in patients with chronic kidney failure and in cancer patients whose anemia is caused by chemotherapy. Epogen and Procrit also are cleared for patients scheduled for major surgery to reduce potential blood transfusions and for the treatment of anemia due to a certain therapy for HIV patients.

The FDA's action follows the publication of research that shows the drugs raise the risk of dangerous side effects in patients with chronic kidney failure. Other recent research reveals the recommended doses of ESA drugs could increase the death risk in cancer patients who weren't receiving chemotherapy. Recommended doses also could raise the risk of blood clots in patients who have undergone orthopedic surgery.

"Amgen is committed to providing timely and appropriate communications to physicians and patients whenever we become aware of new safety information that could affect clinical practice," said Dr. Roger Perlmutter, executive vice president of research and development at Amgen.