Regranex, a foot gel used by diabetics to treat diabetic leg and foot wounds, may increase the risk of cancer and death, U.S. health officials said on Thursday.

The gel, Regranex, manufactured by Johnson & Johnson, caused an increase in the number of cancer deaths among patients who had been prescribed the gel three or more times, the Food and Drug Administration said.

Regranex, approved for U.S. patients in 1997, is a prescription drug.

"At this time, FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex," the FDA said in a statement.

"Because there are known risks associated with diabetic foot and leg ulcers that do not heal, the potential risk of using Regranex should be weighed against the benefit for each individual patient."

Patients with diabetes - a disease in which the body cannot make insulin and affects blood sugar levels - are more susceptible to developing leg and foot wounds because they are less able to feel their feet.

In an earlier study completed in 2001, more cancers were found in Regranex patients than in those who did not use the gel, the agency added. 

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