http://www.nytimes.com/2007/03/10/washington/10fda.html?_r=1&ref=us&oref=sloginThe Food and Drug Administration issued strict new warnings yesterday about overuse of widely prescribed anemia drugs after a flurry of recent studies suggested they might cause heart problems or hasten the death of cancer patients.
The agency said that a “black box” warning — the strongest kind — had been added to the labels of the drugs and that doctors should use the lowest possible dose needed to help patients avoid blood transfusions.
It also said it was re-evaluating the validity of claims in the labels and in advertisements that the drugs can raise energy levels or otherwise improve a patient’s quality of life.
Almost one million Americans take one of the drugs, which are mostly used to treat anemia caused by kidney failure or chemotherapy. The drugs are darbepoetin alfa, sold as Aranesp by Amgen, and epoetin alfa, sold as Epogen by Amgen and as Procrit by Johnson & Johnson.
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The drugs, given by injection, have been heavily advertised, and there is evidence that they have been overused, in part because dialysis centers and oncologists can make money by using more of the drug.
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