From: EXECSEC
Sent: Tuesday, December 05, 2000 3:51 PM
To: Dockets, FDA
Subject: FW: Lotronex



-----Original Message-----
From: Henney, Jane 
Sent: Tuesday, December 05, 2000 1:29 PM
To: EXECSEC
Subject: FW: Lotronex




> ----------
> From: 	
> Sent: 	Tuesday, December 05, 2000 1:28:19 PM
> To: 	Jhenney@oc.fda.gov
> Subject: 	Lotronex
> Auto forwarded by a Rule
> 
To:  Dr Jane Henney

Hello my name is ---------------.  I'm 47 years old and I have been having problems with IBS symptoms for over 15+ years.  Mine got extremely bad after the birth of my daughter and has not subsided until last year.  Last year I was fortunate to be part of one of the many clinical trials - using the drug Lotronex.  It was immediate relief.  

This week I learned the drug has been pulled from the market.  Hopefully you can understand and fully appreciate - that I'm not happy about the turn of events.  I have spoken with Glaxo and I understand that this pill will NOT be returning to the market - not even in limited circumstances.

In addition I have of course contacted my doctor - who informs me - that there is NOTHING on the market to replace this medication.  I can however - participate in another clinical trial - of which I might or might not get the prescription medication.  Therefore - my old life - of having major problems dealing with IBS  return.  I will not be able to enjoy going to the MALL, sporting events, or other locations where bathroom facilities are not IMMEDIATELY available.  Before getting with my current gastroenterologist I was told by DOCTORS that my condition was in my head.  ALL STRESS and or ALL DIET.  Trust me - that just isn't the case.  Those conditions can play a role in my condition - but they can NOT control the IBS.

I doubt seriously - you will react to my little email - but I felt I had to try.  Trust me - if you had my IBS - you would not have pulled this medication.  I understand it may not be for everyone  but to punish those of us - if did - is not in the best interest.  IBS is one of the least talk about problems of today's world.

Sincerely,