From: 
Sent: Thursday, December 07, 2000 10:26 AM
To: fdadockets@oc.fda.gov
Subject: Patient Commentary

Importance: High

 
To Whom Can Help Me
 
I am a 37 year old ------- with severely debilitating IBS (diarrhea predominant)! I can have upwards of fifteen bowel movements a day (minimally eight) without any form to the stool.  These are often accompanied by severe cramping.  Periodically I will be waken from sleep to spend the next three hours in the bathroom having such abdominal discomfort that I believe that I will begin to vomit at the same time I am violently evacuating my bowels.
 
 I have been seeking treatment for this condition for the past 16 years.  I have tried homeopathic remedies, prescriptions, and diets, including two years obtaining from wheat and dairy.  Nothing has worked.  UNTIL NOW!
 
I have been well diagnosed, having had upper and lower GI barium x-rays (7), GI CT scans (1), and upper and lower endoscopies (3) inclusive of biopsies.  The problem is hypermotility of my GI tract, often resulting in painful spasms.  I believe, and so does my physician, that I am the exact patient type for which Lotronex was developed.
 
Despite the FDA approval being directed for female use, my physician prescribed it for me, with the understanding that the dosing would be off, and we would be on our own to find the correct dosage.  We achieved the perfect dose for my 6'4" 220lb frame at 2mg two times daily.  I used Lotronex from March through November.  It did for me what I never believed could be done.  I WAS NORMAL.
 
For the first time in my life, I knew what it was like to have a normal bowel movement, without discomfort, without having to use half of a roll of toilet paper to have to clean myself adequately, and to only have two bowel movements a day.  I cannot adequately express to you the changes in my life resulting from my use of Lotronex.
 
My family stress was significantly reduced or even eliminated, since I was no longer chronically uncomfortable and no longer spent the majority of my waking hours using the bathroom.  I was able to make commitments to go to dinner or attend a meeting and know that I would actually make it.  My concentration improved without the distraction of my gut.  I could go on and on.
 
I have not had any luck in finding an alternative to Lotronex.
 
Can I have your help in working with Glaxo Wellcome to release the drug for compassionate use?  My physician will help any way he can, as will I.
 
Please help me!
 
 
Sincerely