WASHINGTON -- The Food and Drug Administration warned patients yesterday that using large amounts of a Johnson & Johnson foot-ulcer medication could heighten their risk of dying from cancer.
The FDA added the warning to the company's cream medication Regranex, which is used to treat foot and leg ulcers in diabetics. The new warning says that patients who used three or more tubes of Regranex over a 20-month period were five times more likely to die of cancer.
When patients used lower amounts of the cream, the FDA said that their chances of developing cancer were no higher than patients who had never used the drug.
The findings come from an analysis of records from health-care providers comparing 1,600 patients who took Regranex with 2,800 patients who did not, the FDA said.
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