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Boxed warning added to diabetic ulcer treatment.(News)

Information about the increased risk of cancer-related deaths in patients who have used three or more tubes of becaplermin is now included in a boxed warning on the label of the diabetic foot and leg ulcer treatment.

Last month, the Food and Drug Administration announced that the warning had been added to the label of becaplermin (Regranex), a recombinant human platelet-derived growth factor that was approved in 1997. It is marketed as Regranex Gel 0.01% for treating nonhealing diabetic leg and foot ulcers.

The boxed warning says that the increased risk of mortality was observed in a postmarketing retrospective cohort study in patients who had been treated with three ...

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