[IP] Foot gel and possible cancer risk
Diabetes Foot Gel May Have Cancer Risk
By Susan Heavey,
Posted: 2008-03-28 13:57:37
WASHINGTON (March 28) - A Johnson & Johnson foot gel used by diabetics may
increase the risk of cancer and death, U.S. health officials said on Thursday
in announcing an investigation into the issue.
The Food and Drug Administration said a study of the gel, called Regranex,
found an increase in the number of cancer deaths among patients who had been
prescribed the gel three or more times.
Regranex, approved for U.S. patients in 1997, is a prescription gel used to
treat diabetic leg and foot wounds.
"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
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
Barbara Montresor, a spokeswoman for Johnson & Johnson's Ethicon Inc unit
that makes the gel, said the company was working with the agency and that
Regranex is safe when used as directed.
Patients with diabetes -- a disease in which blood levels of sugar are too
high -- are more susceptible to developing leg and foot wounds because they
are less able to feel their feet.
Concern arose following a study of adult diabetes patients through an
insurance plan database that found an increase in cancer deaths from January
through June 2003. No single type of cancer was identified, the FDA said.
The agency did not say who conducted the study or how many patients were
included, and an FDA spokeswoman declined to comment.
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.
Ethicon's Montresor did not immediately respond to a request seeking more
details on the studies.
Shares of Johnson & Johnson closed down 8 cents at $64.62 on the New York
Copyright 2008 Reuters Limited
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