FDA Adds Black Box Warning to Diabetic Ulcer Cream

By Peggy Peck
ROCKVILLE, Md., 08 june 2008-- A boxed warning about increased risk of cancer deaths is being added to the label of becaplermin (Regranex Gel 0.1%), a prescription cream used to treat refractory leg and foot ulcers in diabetic patients, the FDA announced.
The agency said it decided the warning was needed after reviewing data from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to becaplermin and 2,809 controls.
The study found a five-fold increased risk of cancer mortality in patients exposed to three or more tubes of the cream.
There was no overall increase in cancer incidence based on exposure to becaplermin. No single type of malignancy was involved.
Susan Walker, M.D., director of the FDA's division of dermatological and dental products, said the cream was "not recommended for patients with known malignancies."
The FDA initiated a safety review of becaplermin in late March.
The active ingredient in the cream is a recombinant form of human platelet-derived growth factor, which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body.