The Food & Drug Administration (FDA) has required tough new warnings and restrictions for Aranesp, Epogen and Procrit. Yesterday’s announcement that the agency was requiring further label changes and restrictions is the first time the FDA has used authority granted to it in 2007 to force a drug maker to change a drug’s label.
In March, an FDA advisory panel recommended new restrictions for the drug. The FDA mandated label will say that the drugs shouldn’t be used in cancer patients receiving chemotherapy when a cure of their cancer is anticipated. The FDA also ordered inclusion of a statement that the drugs aren’t to be administered when hemoglobin levels are greater than or equal to 10 grams per deciliter. Language is being removed that seemed to imply that it was safe to continue treating patients until their hemoglobin rose to 12 grams per deciliter. (more…)
