Warning Added to Labeling of Diabetic Ulcer Cream

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The FDA announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin), a topical cream indicated for treatment of non-healing leg and foot ulcers in diabetic patients.

 

A retrospective study compared cancer incidence and mortality among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed.

 

While no overall increase in cancer incidence among the patients exposed to Regranex was demonstrated, there was a fivefold increased risk of cancer mortality in the group exposed to three or more tubes of Regranex.

 

“In announcing this label change, FDA still cautions health-care professionals to carefully weigh the risks and benefits of treating patients with Regranex,” said Susan Walker, MD, director of the FDA's Division of Dermatological and Dental Products.

 

“Regranex is not recommended for patients with known malignancies.”

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