Resources for Food and Drug Administration (FDA)

FDA Advisers Recommend More Restrictions for Anemia Drugs

www.medpagetoday.com

Despite more reports on the risks of erythropoiesis-stimulating agents darbepoetin alfa (Aranesp) and epoetin alfa (Epogen, Procrit), FDA advisers have recommended that the drugs stay on the market -- with some additional restrictions.

The Oncologic Drug Advisory Committee said the FDA should mandate a restricted distribution system for cancer patients given erythropoiesis-stimulating agents, a system similar to that used for thalidomide (Thalomid), lenolidomide (Revlimid), and isotretinoin (Accutane).The FDA is not obligated to follow the advice of advisory committees, but it generally does. The panel also agreed that a good threshold for initiation of treatment with darbepoetin or epoetin is a hemoglobin level of 10 mg/dL.

By a vote of 12 to one, the advisory committee agreed that erythropoiesis-stimulating agents should "continue to be marketed for currently approved oncologic indications."

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