FDA evaluates Regranex cancer risk

The FDA is investigating the possibility of an increased risk of cancer in diabetic patients who apply Regranex (becaplermin gel, from Ortho-McNeil) directly to foot and leg ulcers. In a recent study involving patients with no previous history of cancer, the number of patients who died as a result of cancer was higher among those who were prescribed Regranex three times or more. The FDA believes that there may be some evidence for an increased risk of cancer death in patients who had repeated treatments with Regranex. Due to the dangers associated with non-healing diabetic foot and leg ulcers, the potential risk of using Regranex should be weighed against the benefit for each individual patient.

Regranex, a recombinant form of human platelet-derived growth factor, is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm094968.htm.