Cancer warnings added to foot cream

June 8, 2008 10:08:45 PM PDT
Using large amounts of a Johnson & Johnson foot ulcer medication could heighten patients risk of dying from cancer.

That's the warning the Food and Drug Administration issued Friday.

The FDA added its most serious warning to the New Brunswick-based company's cream medication Regranex, which is prescribed to treat severe foot and leg ulcers in diabetics.

The new boxed warning states that patients who used three or more tubes of Regranex were five times more likely to die of cancer.

But when patients used lower amounts of the cream, the FDA said their chances of developing cancer were no higher than patients who had never used the drug.

The findings come from a long-term study comparing 1,600 patients who took Regranex with 2,800 patients who did not, according to the FDA.

The label advises doctors to use caution when prescribing the drug to patients with malignancies.