FDA Ads Cancer Warning to Regranex Foot Gel

The Food and Drug Administration agency has announced that a warning regarding the risk of cancer will be added to Regranex’s label. The product, which is a foot gel, is used to treat ulcerations of feet and legs in patients with diabetes.

The study on which the FDA’s decision was based on was carried on a number of 1,600 patients who were treated with Regranex. 2,800 healthy people were used for comparison.

The study found that while people who used less than three tubes of the foot gel had the same chances of developing cancer like the people who never used it, the ones who were treated with more than three tubes had a five times bigger chance of developing the disease.

The Food and Drug Administration agency also found that there wasn’t any connection between the places where the foot gel was applied and the place where the tumors would appear.

The drug, which is manufactured by Johnson & Johnson, is an artificial version of a substance from the growth factor category that is created by the human body, which makes cells divide more rapidly than usual. If used in conjunction with wound care products, Regranex helps wounds heal faster.

Johnson & Johnson said that it will support FDA in its try to bring the information discovered by the study to the attention of as many doctors as possible, and to convince them of the necessity of being very careful when prescribing Regranex.
After FDA made the announcement, the company’s shares have dropped 93 cents.