FDA Adds Cancer Warning to Regranex Label
The cream for diabetic foot and leg ulcers increases risk of cancer mortality
MONDAY, June 9 (HealthDay News) -- Officials from the U.S. Food and Drug Administration (FDA) have added a boxed warning to the label of Regranex (becaplermin) -- a cream that is used to treat diabetic foot ulcers that fail to heal -- due to an increased risk of cancer mortality in patients who use three or more tubes of the drug.
The label cites a retrospective epidemiological study comparing cancer incidence and mortality in 1,622 patients using Regranex and 2,809 similar patients who were not using the drug.
In the study, Regranex was not associated with any overall increase in cancer incidence but was associated with a fivefold higher risk of cancer mortality in patients who used three tubes or more, according to the FDA. Regranex is a recombinant form of platelet-derived growth factor, and a long-term safety study completed in 2001 had shown more deaths from cancer in patients taking Regranex than in those who did not.
"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, M.D., director of the FDA's Division of Dermatological and Dental Products. "Regranex is not recommended for patients with known malignancies."