FDA group recommends anemia drug limits

An FDA panel has recommended that the agency set prescribing limits for two popular anemia drugs, after concluding that these drugs raise safety concerns. The panel targeted Amgen's Epogen and Aranesp, along with Johnson & Johnson's Procrit (licensed from Amgen). These drugs are prescribed to more than 1 million people in the U.S. each year. Collectively, the drugs sold about $10 billion last year, with Epogen and Aranesp accounting for a staggering 47 percent of Amgen's revenue. The panel members didn't specify what limits they'd like to impose, suggesting that the matter requires further study.

Panel members were responding, in part, to a growing number of studies that have raised questions about the drugs' benefits for some types of cancer patients, as well as others suggesting that high doses could raise heart attack and stroke risks. The recommendation also comes on the heels of a wave of unfavorable coverage suggesting that patients get far too much of these drugs, particularly within dialysis clinics, given that prescribing standards are often very loose and potential profits very high.

To find out more about these issues:
- read this Los Angeles Times article [1]

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Regulators question anemia drugs. Report [3]
New study points to danger of anemia drug. Report [4]
Amgen stock slips as anemia drug concerns rise. Report [5]