FDA forces label-change for Amgen anemia drugs
The USA's Amgen has been made to change the labelling of its drugs Aranesp (darbepoetin alfa) and Procrit (epoetin alfa) under new powers granted to the Food and Drug Administration.
The drugs, for use in the treatment of cancer-induced anemia, are no longer indicated for patients who are expected to survive their cancer or patients who have a hemoglobin level of above 10g per deciliter. The changes come in the wake of recent studies that indicated the agents may shorten life expectancy.
Previously, such changes would have been negotiated with the firm, but under new powers granted by Congress last year Amgen is no longer required to agree to the changes. The company is the first to become subject to the FDA's new powers and has been pushing for more lenient restrictions.
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