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[IP] Foot gel and possible cancer risk



Diabetes Foot Gel May Have Cancer Risk
 
By Susan  Heavey,
Reuters
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
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."
 
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
1998
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 
Stock Exchange.
 
 
Copyright 2008 Reuters  Limited

 


 
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