Important Safety Information

WARNING: INCREASED RATE OF MORTALITY SECONDARY TO MALIGNANCY

An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX (becaplermin) Gel, 0.01% in a postmarketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX Gel should be used with caution in patients with known malignancy.

Important Safety Information

People who use 3 or more tubes of REGRANEX (becaplermin) Gel may have an increased risk of death from cancer.

You should talk with your healthcare provider about the possible benefits and risks to you if you use more than 3 tubes of REGRANEX Gel. If you already have cancer, you and your healthcare provider should carefully consider whether you will use REGRANEX Gel.