The FDA issued a communication on March 27 about its ongoing safety review of Regranex (becaplermin gel, Ortho-McNeil), a topical medicine applied directly to the foot and leg ulcers of patients with diabetes.

 

The agency believes there may be evidence for an increased risk of death from cancer in patients who have been treated with the gel repeatedly. Health-care professionals are urged to report serious and unexpected adverse reactions associated with Regranex to the FDA MedWatch reporting program at www.fda.gov/medwatch/report.htm.

 


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The FDA stated that it “is considering, but has not reached a conclusion about whether this information warrants any regulatory action,” pending analysis of additional data.