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The Food and Drug Administration agency has announced that a
warning regarding the risk of cancer will be added to Regranex’s label. The
product, which is a foot gel, is used to treat ulcerations of feet and legs in
patients with diabetes.
The study on which the FDA’s decision was based on was carried on a number of
1,600 patients who were treated with Regranex. 2,800 healthy people were used
for comparison.
The study found that while people who used less than three
tubes of the foot gel had the same chances of developing cancer like the people
who never used it, the ones who were treated with more than three tubes had a
five times bigger chance of developing the disease.
The Food and Drug Administration agency also found that there wasn’t any
connection between the places where the foot gel was applied and the place
where the tumors would appear.
The drug, which is manufactured by Johnson & Johnson, is an artificial
version of a substance from the growth factor category that is created by the
human body, which makes cells divide more rapidly than usual. If used in
conjunction with wound care products, Regranex helps wounds heal faster.
Johnson & Johnson said that it will support FDA in its try to bring the
information discovered by the study to the attention of as many doctors as
possible, and to convince them of the necessity of being very careful when
prescribing Regranex.
After FDA made the announcement, the company’s shares have dropped 93 cents.
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