Skip to content
My WebMD Sign In, Sign Up
Font Size

Warning for Regranex--Cream for Leg and Foot Ulcers

On June 6, 2008, the Food and Drug Administration (FDA) announced that a boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin). The warning addresses the increased risk of cancer death in patients who use three or more tubes of the product.

Regranex is a topical cream for treating leg and foot ulcers that are not healing in patients with diabetes. A boxed warning on a drug's label calls attention to serious or life-threatening risks.

Recommended Related to FDA Center

Lowering Salt in Your Diet

Lowering Salt in Your Diet Everyone needs some salt to function. Also known as sodium chloride, salt helps maintain the body's balance of fluids. Salt also functions in many foods as a preservative, by helping to prevent spoilage and keeping certain foods safe to eat.  But nearly all Americans consume more salt than they need, according to the 2005 Dietary Guidelines for Americans. These guidelines are published every five years by the U.S. Department of Health and Human Services and the U...

Read the Lowering Salt in Your Diet article > >

What is the basis for the revised label?

A study compared cancer incidence and cancer death among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed to the product. Although the study showed no overall increase in cancer incidence among the patients exposed to Regranex, there was a five-fold increased risk of cancer death in the group exposed to three or more tubes of the product.

What is FDA advising in regard to Regranex?

In announcing this label change, FDA cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex. The product is not recommended for patients with known malignancies (cancerous tumors).

FDA urges health care professionals to promptly report serious and unexpected adverse reactions associated with Regranex to FDA's MedWatch reporting program. MedWatch reports may be submitted the following ways:

For more information about topics for your health, visit the FDA Consumer Information Center ( 

Return to the Protect Your Health Homepage

WebMD Public Information from the FDA