Regranex Diabetic Foot Gel Gets Boxed Warning

Scott Kappes

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Today the FDA informed healthcare professionals that a boxed warning has been added to the label of Regranex gel because of an increased risk of cancer and death observed in patients that have been treated with three or more tubes of the gel. Regranex is used to help heal leg and foot wounds commonly experienced by many diabetics. In March the FDA issued an early communication to warn patients that study data suggested these increased risks might exist.

The findings come from a long-term study comparing 1,600 patients who took Regranex with 2,800 patients who did not, according to the FDA.

Regranex is a man-made version of a substance produced by the human body that helps heal ulcers. Because the drug causes cells to divide more rapidly, the FDA said Johnson & Johnson closely monitored patients for reports of cancer, which spreads through uncontrolled cell division.

Over 750,000 people have used Regranex since it received FDA approval in 1997. It is shame that we are only finding out about these serious risks now.