From: EXECSEC Sent: Tuesday, December 05, 2000 3:50 PM To: Dockets, FDA Subject: FW: I am a successful Lotronex user!!! -----Original Message----- From: Henney, Jane Sent: Tuesday, December 05, 2000 1:32 PM To: EXECSEC Subject: FW: I am a successful Lotronex user!!! ---------- From: Sent: Monday, December 04, 2000 1:38:27 PM To: woodcockj@cder.fda.gov; jhenney@oc.fda.gov Subject: I am a successful Lotronex user!!! Auto forwarded by a Rule Dear Dr. Jane Henney and Dr. Janet Woodcock, I have been a Lotronex user for nine months and it has given me back my life. I am extremely upset that Lotronex has been removed from the market. I have diarrhea predominant irritable bowel syndrome and have had it for about 15 years with it getting progressively worse. I am under the care of two very good doctors and with their guidance I do not believe that Lotronex will cause me a risk that it is worth my giving it up. When I first started taking the Lotronex, I tried some samples and was told to take two a day, one in the morning and one in the evening, and if that was too much, then take a half. I could tell the first day that one in the morning and one in the evening was too much for my system, and I could get constipated. Thus, I started breaking the pill in half, taking one-half in the morning and the other half at bed time. On days when I knew that I might be eating out at lunch or dinner, or in some other stressful situation, I would take either one in the morning or the evening with a half at the other time of the day. This has worked very well for me. I still have to watch what I eat and drink. I can not have much caffeine, foods with high fiber content such as apples and salads, or spicy foods. I even keep to a very restricted intake of fluids. I know I should drink more because my urine is always very yellow. But, I have learned that if I drink too much, it just goes through my colon rather that through my kidneys and I have more diarrhea. I have learned to eat small volume meals and I continue to do that. Before Lotronex, even with monitoring my foods I could not eat out many times and places and could not travel without having quick access to a bathroom. It has become a standing family joke that if we are traveling and I say I need a bathroom, that has to be immediately provided. I always carry toilet paper in every vehicle and have had to stop on the side of the road many times. It used to be embarrassing, but now we just joke and go on with it as a way of life. I even thought about getting one of those very small travel vehicles as my regular vehicle to drive just to have my on portable potty at all times. BUT, with Lotronex, there has been a vast improvement. I can now travel without having to make frequent and sudden stops. I can go out to eat without having to use the bathroom before I leave the restaurant and with perhaps one or two stops on the way home. I am 58 years old and at this point in my life I do not consider taking Lotronex any more serious a risk than the Prempro that I am taking. I value the quality of life that I now have from taking the Lotronex and it is worth more to me than the concern about the health risk. I understand your concern for the general public, but I believe that I should have the choice about taking Lotronex. I just recently refilled my prescription and plan to continue taking it until it is all gone. I will continue to be under my doctor's care about this medication. My prescription drug provider, ---------- , has advised me that they will no longer be supplying Lotronex. Since I get my medication on a drug program as part of my medical insurance, it is sufficiently economical for me to take it. I would appreciate your giving serious consideration to finding a way to put this medication back on the market. I understand the risks and the problems about constipation, but as I said, I think that I should have the option to make the decision about taking Lotronex. Thank you