Amgen, J&J fall on anemia drug study

The treatments increase blood clot and death risks, according to a leading medical journal, but the companies say it points out nothing new.

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By Aaron Smith, CNNMoney.com staff writer

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NEW YORK (CNNMoney.com) -- Shares of Amgen and Johnson & Johnson took a hit Wednesday after a study showed their anti-anemia drugs increase the risk of blood clots and death in cancer patients. But the companies say it's old news.

The study, published in the Journal of the American Medical Association, found patients using drugs that are considered erythropoiesis-stimulating agents, or ESAs, increase their risk of death by 10%. They also increase by 57% the risk of developing deep vein thrombosis, or blood clots in the leg and lungs, the study said.

Amgen's (AMGN, Fortune 500) Aranesp and Epogen and Johnson & Johnson's (JNJ, Fortune 500) Procrit are ESAs. They're typically used with chemotherapy to ward off blood-cell reduction associated with chemo.

Amgen's stock price dropped 2% in afternoon trading, while Johnson & Johnson dipped about 1%.

Dr. Charles Bennett of the Northwestern University Feinberg School of Medicine in Chicago led the study, which compiled and examined data from 51 prior studies in more than 13,000 patients.

This is not the first time problems have arisen for the ESA class. Bret Holley, a drug analyst for Oppenheimer & Co., dismissed the JAMA report as "old news," despite its apparent impact on company stocks.

In 2007, the increasingly-cautious Food and Drug Administration toughened warning labels for ESAs to reflect the potentially fatal side effects of taking them in high doses. These drugs are a major part of Amgen's franchise, and the ongoing safety concerns are largely responsible for the biotech's stock losing one-third of its value in 2007.

On March 13, the FDA will hold an advisory meeting on the safety risks of ESAs.

In a statement emailed to CNNMoney.com, Amgen said the study "does not define any new risks associated with ESAs, and the risk of [deep vein thrombosis] is included in current labeling and has been for some time. It's important that physicians and patients fully understand the benefit (transfusion avoidance) and risks and that these drugs be used appropriately according to the FDA approved labeling."

But Dr. Bennett said his study is the first to reveal an increase in the risk of death.

Johnson & Johnson insisted its drug is safe. Its subsidiary, Ortho Biotech, which makes Procrit, accused the study of being inaccurate.

"The company reaffirms that, when used according to product labeling, ESAs remain safe and effective and are the only proven treatment alternative to blood transfusions for patients with [chemotherapy-induced anemia,]" Ortho said in a prepared statement emailed to CNNMoney.com.

Dr. Bennett said his analysis focused on patients who used the drug on-label and off-label, and found risks in that overall group. To top of page

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