Anemia Drugs Get Black Box Warning from FDA

Joe Saunders

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The FDA has issued a "black box" warning concerning a family of anemia drugs that have high cancer and heart risks associated with them. The news was a particularly harsh blow to Amgen. The biotech giant alone accounted for $5.3 billion in U.S. sales from its best-selling products Aranesp and Epogen in 2006. Johnson & Johnson's Procrit fetched another $2 billion in U.S. sales. Roche Group AG, Basel, Switzerland, plans to launch its rival product, Cera, this spring despite a bitter patent battle with Amgen that has divided the onetime partners.

FDA officials said the black box was sparked by recent studies that have pointed to risks tied to the drugs, particularly when doctors used them for very aggressive treatments.