Today the FDA informed healthcare professionals that a boxed
warning has been added to the label of Regranex gel because of an increased risk of cancer and death observed in patients that have been treated with three or
more tubes of the gel. Regranex is used to help heal leg and foot wounds
commonly experienced by many diabetics. In March the FDA issued an early
communication to warn patients that study data suggested these increased risks
might exist.
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.
Regranex is a man-made version of a substance produced by
the human body that helps heal ulcers. Because the drug causes cells to divide
more rapidly, the FDA said Johnson & Johnson closely monitored patients for
reports of cancer, which spreads through uncontrolled cell division.
Over 750,000 people have used Regranex since it received FDA approval in 1997. It is shame that we are only finding out about these
serious risks now.
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