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New trouble for Amgen

The government says that two studies confirm the potential danger of anemia drugs sold by the Thousand Oaks-based company, as well as those made by Johnson & Johnson. The studies showed women with advanced breast and cervical cancer died sooner or had faster tumor growth when taking the drugs at higher-than-recommended levels. Doctors have prescribed them at those higher doses, even though the FDA doesn't approve. You might recall that based on earlier studies the feds have added "black box" warning labels to the drugs (Amgen's Aranesp and Epogen), emphasizing their risks at elevated levels in patients with other types of cancer. Here's some backstory from the LAT:

Known as erythropoietin stimulating agents or ESAs, the anemia drugs are bioengineered versions of a natural protein made in the kidney that stimulates bone marrow to produce more red blood cells. Cancer and dialysis patients use injectable ESAs to treat anemia and boost energy. Fallout from the earlier studies' findings rankled patients and regulators. The FDA added the black box warning last year and the federal Medicare agency followed with limits on what dosages of anemia drugs it will reimburse, affecting the company's sales. The results of the two most recent research studies appear to reinforce concern that some cancer patients die sooner when taking the drugs than those who don't.

The stock hit another 52-week low on Thursday before closing at $45.69. It's traded as high as $76.95 in the last year.


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