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FDA Date: 6/5/08
Regranex (becaplermin) FDA Drug Safety Communication
Update of Safety Review: Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Regranex (becaplermin)
FDA has completed its review of 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. FDA 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.
In response, the manufacturer of Regranex has added this information and a Boxed Warning to the labeling for the product. FDA recommends that Regranex be used only when the benefits are expected to outweigh the risks described in the labeling.
This information reflects FDA's current analysis of available data concerning this drug.