Amgen Told to Reword Drug Label

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July 31, 2008

Amgen Told to Reword Drug Label

By ANDREW POLLACK

The Food and Drug Administration has ordered Amgen to change the labels for its

flagship anemia drugs in a way that could further restrict their use in treating

patients with cancer.

The move, which the F.D.A. announced on Wednesday, represents the first time the

agency has invoked authority under a 2007 law that empowered it to order changes

in a drug's prescribing information. Previously, the F.D.A. could only negotiate

with a drug's manufacturer to change the label.

Sales of the drugs, Aranesp and Procrit, have already plummeted in the last year

because of studies suggesting that their use to treat the anemia caused by

chemotherapy could actually make cancer worse or shorten lives. Procrit is

manufactured by Amgen but sold under license by & .

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