FDA Panel: Anemia Drugs Need Risk Warnings

Government advisers said Thursday Amgen Inc. and Johnson & Johnson should be required to add new warnings and conduct additional safety studies of their blockbuster anemia drugs.

The Food and Drug Administration's outside panel of experts voted overwhelmingly in favor of expanding existing warnings about the risks of death, blood clots and other side effects when Amgen's Aranesp and Johnson & Johnson's Procrit, are prescribed outside of approved uses.

The panel of experts, at a meeting in a hotel here, also voted unanimously that the companies should be required to conduct new studies to definitively prove the safety of the two widely prescribed drugs. They were first approved to treat anemia in the early 1990s.

Anemia drugs accounted for $10 billion in revenue for these two companies last year alone.

The FDA is not required to follow the panel's recommendations although it typically does.

Shares of Amgen fell $3.83, or 6.1 percent, to $59.25 on heavy trading volume and Johnson & Johnson shares fell 95 cents, or 1.5 percent, to $63.16 in afternoon trading.