FDA orders boxed warning for Regranex

WASHINGTON, June 9 (UPI) -- The U.S. Food and Drug Administration announced the addition of a boxed warning for Regranex (becaplermin) because of an increased risk of cancer mortality.

The warning includes updated epidemiological data about the increased risk for diabetic patients who use three or more tubes of the topical cream that's indicated for the treatment of leg and foot ulcers that aren't healing.

The FDA said a retrospective study compared cancer incidence and cancer mortality among 1,622 patients exposed to Regranex with 2,809 otherwise similar patients who weren't exposed. The results were consistent with no overall increase in cancer incidence, but there was a five-fold increased risk of cancer mortality in the group exposed to three or more tubes of Regranex.

"In announcing this label change, FDA still cautions healthcare professionals to carefully weigh the risks and benefits of treating patients with Regranex," said Dr. Susan Walker, director of the FDA's Division of Dermatological and Dental Products. "Regranex is not recommended for patients with known malignancies."

Regranex is a medicine that is a recombinant form of human platelet-derived growth factor that is applied directly to diabetic foot and leg ulcers that aren't healing.