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Regranex MedWatch Cancer

Executive Summary

FDA is investigating the potential for increased risk of death among diabetic patients receiving Johnson & Johnson's Regranex (becaplerim), FDA says in a March 27 MedWatch alert. In a study using a health insurance plan database of patients with diabetes with no history of cancer, among those who applied Regranex three or more times to foot and leg ulcers, there was an increase in the number of patients who died as a result of cancer. While evaluating the mortality signal, FDA is advising physicians to weigh the evidence for increased risk of death against the risks associated with diabetic foot and leg ulcers that do not heal...

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