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US FDA Announces New Labelling Changes for Becaplermin ROCKVILLE, Md -- June 7, 2008 -- The US Food and Drug Administration today announced the addition of a boxed warning to the label of becaplermin (Regranex Gel 0.01%) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Becaplermin is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in patients with diabetes. The Warnings section of the product has been updated to include a boxed warning and a description of the epidemiologic data that is the basis for the revised label. These data come from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to becaplermin with 2,809 otherwise similar patients who were not exposed. The results were consistent with no overall increase in cancer incidence among the patients exposed to becaplermin. However, there was a 5-fold increased risk of cancer mortality in the group exposed to 3 or more tubes of becaplermin. "In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with [becaplermin]," said Susan Walker, MD, Division of Dermatological and Dental Products. "[Becaplermin] is not recommended for patients with known malignancies." SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version