FDA Highlights Regranex Foot Ulcer Gel Cancer Warnings

On Friday, the FDA announced a new “black box” warning for Johnson & Johnson’s Regranex foot gel. The prescription topical cream is used by diabetics to treat leg and foot ulcers which are not healing. The warning indicates that when large amounts of Regranex are used, it could increase the risk of death from cancer.

The warning summarizes the findings of a long-term analysis of records that involved about 4,400 patients. When the incidence of cancer and cancer deaths among those exposed to Regranex was compared with similar patients who were not exposed, researchers found that those who used three or more tubes faced a five times greater risk of death from cancer.

Regranex Gel 0.01% (becaplermin) was approved by the FDA in December 1997. Due to the fact that the diabetic foot cream causes cells to divide more rapidly, the Johnson & Johnson and FDA have been monitoring studies for evidence of an increased risk of cancer. After a study completed in 2001 first identified that there were more deaths from cancer among people who used Regranex than those who did not, a follow up study was done to review information in a health insurance database which covered treatments between January 1998 and June 2003.

The new warning will be placed on the label in a prominently displayed “black box”, which is the strongest warning that can be placed on a prescription medication. The new boxed warnings states:

An increased risk of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX Gel in a post-marketing retrospective cohort study. REGRANEX Gel should be used with caution in patients with known malignancy.

No particular type of cancer has been identified in connection with Regranex Gel. The increased risk was observed when deaths from all types of cancer were combined. The FDA has urged doctors to report all serious and unexpected adverse reactions potentially caused by Regranex side effects to the FDA MedWatch reporting program.

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