From: 
Sent: Thursday, December 07, 2000 7:48 PM
To: JHenney@oc.fda.gov
Cc: Woodcockj@cder.fda.gov; fdadockets@oc.fda.gov
Subject: LOTRONEX 
Dear JHenney: 

Four years ago I was diagnosed with colon cancer and had a colon resection.  
Since that time I have be plagued with such severe irritable bowl syndrome 
that for days at a time I am house bound in severe pain resulting from  
constant diarrhea and severe colon spasm.  The only solution until last 
spring was high doses of valium and vicodan.  With those medications, the 
pain would subside yet all I was able to do was sleep.  My life had been 
saved, but I had lost my life. 

Prior to my diagnosis, I was an active private pilot, taught seventh grade 
and ran a business, and was able to participate in several plays and 
commercial voice overs per year.  From December 1996 until June 2000, I felt 
lucky when I could just get through a full day at school.  Then, in May 2000 
my pharmacist told me about LOTRONEX.  For one month my colon surgeon and I 
researched the medication (at one time, I had been a doctoral student in 
pharmacology), and realizing I fit the criteria for the use of 
LOTRONEX--constant diarrhea with strong spasm--began treatment.  I found that 
only one 1 mg dose per day controlled my symptoms.  I could resume flying, my 
business was growing, and I could enjoy the active social life that I had 
forfeited these past four years. 

Now, one week without LOTRONEX, I am house bound in pain, spasm, and 
continual diarrhea.  I am not always able to complete a full day at work.  
LOTRONEX is a life saver for those for whom it was designed.  Please, I beg 
you, to consider putting LOTRONEX back on the market with provisions that it 
be used only for those of us who meet the criteria for it's use.  Please give 
me my life back. 

Sincerely,