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◊ Gel 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.