US Pharm. 2008;33(8):23. 

The FDA added a boxed warning to the label of Regranex Gel 0.01% (becaplermin)--a topical cream for treating stubborn leg and foot ulcers in diabetic patients--due to increased risk of death from cancer. The action stems from a long-term safety study completed in 2001 comparing cancer rates and mortality among 1,622 patients exposed to Regranex and 2,809 otherwise similar patients who were not exposed. The results showed no overall increase in cancer incidence among the patients exposed to Regranex. However, the results indicated that there was a fivefold increased risk of cancer mortality among patients exposed to three or more tubes of the product.

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

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