From: EXECSEC Sent: Thursday, December 07, 2000 4:05 PM To: Dockets, FDA Subject: FW: Withdrawal of Lotronex from the Market -----Original Message----- From: Henney, Jane Sent: Thursday, December 07, 2000 2:25 PM To: EXECSEC Subject: FW: Withdrawal of Lotronex from the Market ---------- From: Sent: Thursday, December 07, 2000 2:22:08 PM To: jhenney@oc.fda.gov Cc: woodcockj@cder.fda.gov Subject: Withdrawal of Lotronex from the Market Auto forwarded by a Rule I have been taking Lotronex since April and have had wonderful results. My life has returned to a more normal existence. For those who do not deal with this horrible IBS. you can have absolutely no idea what the quality of life is like for those of us who do deal with it daily. Just imagine you have a virus which affects you with diarhea -- not just a 24-hour bug, but a daily one - 24 hours a day. Someone decides the medication you're taking to stop that diarhea should not be available to you because it made a few people sicker. Well, that's what this withdrawal does to us -- it leaves us with no relief, confines us to our home. I have a variety of feelings in this regard -- first, outrage at a "consumer advocate" group who don't have a clue as to how this IBS affects those who have it. I resent this group usurping control over my life -- who appointed them guardians over me? I am an American, am supposed to have freedom to a pursuit of happiness -- surelysd as Americans, we still have some freedoms left!! I am requesting that you use your influence to get this medication made available to us once again -- the directions provided by the manufacturer are explicit in the guidelines given. If you follow the instructions, do not have good results, then discontinue it, but for God's sakes! don't take it away from those who can take it and have good results. Thank you for your help.