FDA adds black box warning to Regranex

WASHINGTON The Food and Drug Administration has added a black-box warning to Johnson & Johnson’s foot ulcer medication Regranex, warning that when used in large amounts, it could heighten the risk of patients dying from cancer.

The new boxed warning states that patients who used three or more tubes of Regranex over a 20-month period were five times more likely to die of cancer. When patients used lower amounts of the cream, the FDA said their chances of developing cancer were no higher than patients who had never used the drug.

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.

Back in March, the FDA said it was reviewing the drug's links to cancer.