WEDNESDAY JUNE 11, 2008 (foodocnsumer.org) -- The Food and Drug Administration offered some explanation on its website why a boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin), which is used by diabetes patients to treat foot ulcers.

On June 6, 2008, the FDA announced the label change to address the increased risk of cancer death in patients who use three or more tubes of the product.

Regranex is a topical cream indicated for treatment of 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.

The decision, according to the agency, is based on a study that compared 1,622 diabetes patients exposed to Regranex with 2,809 otherwise similar patients for cancer incidence and cancer death.

The study found the cancer incidences were not significantly different between the two groups of diabetes patients.   But the cancer deaths in the Regranex group were five times higher than that in the control group.

In response to the findings, the FDA announced the label change and cautioned health care professionals to carefully weigh the risks and benefits of treating diabetics with Regranex.

This product is not recommended for patients with known malignancies or cancers, the FDA said today on its website.

In addition, the agency urged healthcare providers to promptly report serious and unexpected adverse reactions associated with Regranex to FDA's MedWatch reporting program.