From: EXECSEC
Sent: Wednesday, December 06, 2000 1:21 PM
To: Dockets, FDA
Subject: FW: 



-----Original Message-----
From: Henney, Jane 
Sent: Wednesday, December 06, 2000 1:18 PM
To: EXECSEC
Subject: FW: 




> ----------
> From: 	
> Sent: 	Wednesday, December 06, 2000 1:10:20 PM
> To: 	JHenney@oc.fda.gov; WoodcockJ@cder.fda.gov
> Auto forwarded by a Rule
> 
December 6, 2000





To Whom It May Concern:
I am writing this letter today about a subject that has recently both
angered and saddened me, and I know a lot of others it has affected also.
It is in regard to the prescription drug Lotronex being taken off the
market. 
I have been an irritable bowel syndrome sufferer for six years. What
started out one-day as a simple stomach ache with frequent lose bowel
movements turned into a steadily getting worse problem. Over the past
couple of years I have had many procedures done to rule out any other
serious problems. Many doctors have said that it's only IBS, nothing to
worry about. But they are wrong. While it may be IBS, they don't seem to
realize that it isn't just a syndrome anymore. It is a completely
embarrassing, debilitating, painful, life-altering disease for many of us
that suffer from it day after day. 
While trying to continue with as normal of a life as possible while
dealing with this illness, I, like many others, have lost jobs, our
self-esteem, family, and ability to cope with many of the aspects of how
this disease has changed our lives. I used to be a very active
spontaneous person who enjoyed bike riding, rollerblading, horseback
riding, shopping, driving, and especially playing with my young children
and taking them places to have fun. For quite a few years I could not do
that anymore. The pain of IBS and the frequent bathroom trips, and the
absolute sick feeling that goes along with having IBS has prevented me
from having that fun anymore. Do you know what it feels like to have your
little girl ask for you to play barbies with her and not be able to
because you are in so much discomfort that it is hard to breath, or how
about when your son asks you to play a game with him, but you are too
sick. The look on their faces when I tell them that I can't take them to
the beach or to the park or have them sit on my lap anymore because it
hurts too much, is more than a mother can bear. 
Then a pharmacy company came out with Lotronex. I was skeptical before
taking it because all other medications that I had taken to try to
alleviate some of the symptoms of IBS failed. But after one single week
of being on the medication I felt relief. Granted it wasn't complete
relief but enough that I actually could make it to the store and back
without complications. This medicine to me was my savior. After being on
2mg twice a day for many months I felt like a real person again. I was
able to go out and do things with my children and my husband, I was able
to enjoy myself most days, and I started to remember what an hour or even
a day without pain was like. 
But now all that is going to change again. Looking at the complications
and medical problems some have endured from this medication is
heartbreaking. I really feel for those that thought this medication was
the best thing they ever had before and felt that they could finally live
life again outside their homes, only to have bad things happen. But then
you look at the numbers of the deaths, the instances of rupture or
ischemic colitis, or even some common side effects and think to yourself
'out of the many many people taking this medication and getting help from
it, those numbers just don't seem enough to make the thousands and
thousands of people getting relief from it have to suffer by removing
it.' 
I know that there are always risks with any medication, especially new
ones, but this medication hasn't been out that long and if you look at
how many it has helped compared to how many it has hurt. You have to
realize that taking this medication off the market is detrimental to more
and more of us. 
All I know is that I have been off the Lotronex since November 30, 2000
and my symptoms are coming back worse and worse each day. I don't want to
go back to what my quality of life was before Lotronex, mentally or
physically. I have talked to others that have felt much relief from this
medicine and know that them like myself would go back on it in a
heartbeat if it became available again to us. We know there are risks,
life itself is a risk. I can't really speak for others but for myself
quality of my life is more important to me than quantity. I can say that
with all honesty because I am a person that also has a lot of other
medical problems that are more of a concern to me, such as, I have
Multiple Sclerosis, Heart palpitations, I have had 2 major strokes- one
at 19 and one at 23, I have blood clots in my legs, and I have lymphoma.
So you see, the risks associated with taking the Lotronex don't really
bother me. I would rather be able to live they way I want to and did
while on the Lotronex, than to not have it all and just whither away. I
have been fighting to get my health on track and try not to dwell on the
negatives of all the other problems. While on the Lotronex I was able to
put aside all my problems and pain and fears of which problem will kill
me first. IBS is not a deadly disease, but it is more debilitating to
most of us that have it. And it's more debilitating than any other health
problems that I currently have. 
I believe that if people were informed of the risks of this medication
and were given the choice to take it, risks and all, and if they have
already, like myself, tried basically all other medications on the market
they would make an informed decision to take the medicine. Or even just
make the medication available to those that have tried other routes to
alleviate symptoms and pain to no success, that would be most helped by
the Lotronex. Now I'm not saying give it to everyone with IBS, but maybe
with closer testing and evaluation by our primary care providers it
should be available to those that would benefit most from it. Please give
it some thought and consideration and do the research, see how many
people this medication has helped and weigh that with the amount that
weren't. See where the biggest difference was made.
Please feel free to contact me if you have any other further questions at

Sincerely,

Severe IBS sufferer