From: 
Sent: Wednesday, December 06, 2000 9:26 AM
To: fdadockets@oc.fda.gov
Cc: cym72658@glaxowellcome
Subject: lotronex withdrawal-docket#opp1499cpi

>Date: Wed, 06 Dec 2000 09:22:37 -0500
>To: woodcockj@cder.fda.gov
>From: 
>Subject: lotronex withdrawal.
>Cc: cym72658@glaxowellcome
>
>Hello,
>
>Yes, it is me again.  The news this morning reported that due to potential
suicide problems, people taking Accutane would sign a statement explaining
the risks when taking this drug.  Why can't that same thing be done with
Lotronex?  Any patient would read and sign a clearly written statement of
possible side effects of Lotronex and what should be done if constipation,
cramping, blood in stool, etc, did happen.  There are many potential side
effect, ranging from serious to fatal, from most medicines or medical
procedures and thus Lotronex is no different.  Please give me, the patient,
the choice of using Lotronex under the supervision of my physician.  I want
my quality of life to be full and IBS makes my life hell.  After more than
two decades of misery I finally had relief with Lotronex.  I was able to
plan my life, not have my life contolled by IBS.  Nothing I have ever taken
worked as well as Lotronex and there were no side effects.  I don't think
that the FDA knows the hell that IBS causes in its victims.  Please let the
physician and the patient decide on what is best.  I believe thousands have
used this drug with amazing results.  Please don't make the regulations
regarding Lotronex so tight that the manufacturer cannot market it
profitably.  Why treat Lotronex differently than thousands of other drugs
on the market that may cause serious harm or death when taken incorrectly
or different from manufacturer's instructions.  All material I received
before taking Lotronex and an update on my last refill clearly stated
Lotronex's possible side effects and when the use of Lotronex should be
immediately stopped.  The company couldn't make it any plainer than that.
I am now back on tylenol 3 and tincture of opium.  It would be possible for
me to improperly use these but I clearly follow the directions for use.
The problem with Lotronex was not the drug but the patient's continued use
when the drug information clearly indicated otherwise.  Please reconsider
your ruling that made Glaxo Wellcome remove Lotronex from the market.
Lotronex was safe an effective when properly used by patients with IBS.
>
>Sincerely,
>
>