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U.S. Department of Health and Human Services

For Consumers

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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.

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:

    • online at MedWatch Reporting
    • by returning the postage-paid FDA form 3500 (available as a PDF at MedWatch Reporting) to 5600 Fishers Lane, Rockville, MD 20852-9787
    • by faxing the form to 1-800-FDA-0178
    • by phone at 1-800-332-1088

This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.

Date Posted: June 11, 2008


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