Update of Safety Review
Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Regranex (becaplermin)

This information reflects FDA's current analysis of available data concerning this drug.

On March 27, 2008, FDA announced that it had received information about a postmarket epidemiologic study that was performed to investigate the possibility of an increased risk of cancer in patients with diabetes who applied the product Regranex (a topical medicine) directly to their foot and leg ulcers (Communication about an Ongoing Safety Review of Regranex (becaplermin). At that time, FDA committed to communicate its conclusions and resulting recommendations to the public after it had completed its review of the available data.

FDA has now completed its review of the study, and has concluded that the increase in the risk of death from cancer in patients who used three or more tubes of Regranex was five times higher than in those patients who did not use Regranex. However, the risk of getting new cancers among Regranex users was not increased compared to non-users. The duration of follow-up of patients in this study was not long enough to detect new cancers. In response, the manufacturer of Regranex has added this information and a Boxed Warning to the labeling for the product.

When Regranex is used with good ulcer care practices (e.g. removing dead tissue, relieving pressure, controlling infection), it increases the chance of complete healing of diabetic ulcers, a type of ulcer with few other treatment options. Complications from infections of foot ulcers are one of the leading causes of hospitalization in patients with diabetes. FDA recommends that Regranex be used only when the benefits are expected to outweigh the risks described in the labeling. The updated labeling describes the information that led to the new Boxed Warning.

FDA is issuing this follow-up communication in keeping with FDA's commitment to inform the public about its ongoing safety reviews of drugs.

The FDA urges both healthcare professionals and patients to report side effects from the use of Regranex to the FDA's MedWatch Adverse Event Reporting program.

• online at www.fda.gov/medwatch/report.htm
• by returning the postage-paid FDA form 3500 available in PDF format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787
• faxing the form to 1-800-FDA-0178
• by phone at 1-800-332-1088

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Date created: June 6, 2008

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