July 31, 2008 - 10:20 a.m.
WASHINGTON (AP) - The Food and Drug Administration has ordered changes in the prescribing accusation for two widely used anemia drugs, saying the risks of the medications outweigh the benefits in quest of certain cancer patients.
Anemia is a frequent side result of cancer treatment, and can leave already frail patients in an even added debilitated rank. The drugs at issue, Aranesp and Procrit, are commonly used to treat such patients and are made by California-based Amgen. But recent studies have indicated that the treatments could worsen some cancers, and might even shorten patients' lives.
Dr. Richard Pazdur, head of the FDA's oncology section, said Wednesday's directive was the first time the direction has invoked new powers Congress granted it last year to law unsalable article makers to make changes in their prescribing literary productions, also known as the drug label. Previously, so changes had to be negotiated.
The FDA ordered two specific changes:
The agency said the drugs should not be used with patients who are expected to be cured of cancer. Amgen had pressed for language that would have allowed the medications to be used for some patients who are expected to be cured, but who are not skilful to receive transfusions of red royal line cells.
The second change said patients should not be treated with the drugs unless their hemoglobin levels drop below 10 grams per deciliter of blood. The company had asserted the drugs should also be an option for treating some patients with a scornfully higher hemoglobin make horizontal.
The FDA's battle brings the agency into line with a new Medicare policy that restricts payment for the drugs.
Amgen said in a statement the changes ordered by the FDA were "consistent" with the company's expectations.