New Regranex Label Warns of Increased Cancer Risk

ROCKVILLE, Md. - Johnson & Johnson's Regranex will now include a boxed warning that patients who use three or more tubes of the topical cream have a five-fold increased risk of death from cancer, the U.S. Food and Drug Administration announced June 6.

Regranex (becaplermin) was approved in 1997 for treatment of foot and leg ulcers in diabetic patients. The product was the subject of two studies that compared cancer incidence and cancer mortality among patients exposed to Regranex to patients with similar diagnoses and drug use who were not exposed. Both studies showed that deaths from cancer were higher …