From: EXECSEC Sent: Monday, December 11, 2000 7:52 AM To: Dockets, FDA Subject: FW: LOTRONEX -----Original Message----- From: Henney, Jane Sent: Friday, December 08, 2000 6:19 PM To: EXECSEC Subject: FW: LOTRONEX > ---------- > From: > Sent: Friday, December 08, 2000 6:19:21 PM > To: JHENNEY@OC.FDA.GOV > Subject: LOTRONEX > Auto forwarded by a Rule > I would like to address the recent decision by the FDA to remove Lotronex from the market. I have been an IBS sufferer for most of my life. When I was younger, I was hospitalized twice for dehydration from diarrhea. I have found that as I age, I am now 57, the IBS is increasing in frequency and severity. It is not unusual for me to have two to three bouts of diarrhea a week. The most common trigger for my episodes are foods and travel. Let's discuss food. I can't eat any dairy, caffeine, chocolate, fruit juices, any fatty or fried foods, and some vegetables. Granted many of these items aren't good for you, but because of my total intolerance to any dairy foods I have beginning osteoporosis. Because I have an extremely sensitive stomach I can't tolerate calcium pills, they nauseate me. Therefore, when I began using Lotronex last July, I was delighted to find I could tolerate dairy products. Lotronex changed my life and allowed me to eat a more balanced diet. I can now go to lunch with my friends and not worry if I accidentally get a touch of dairy food in my meal and have to spend the next several hours in the bathroom. I not only get severe diarrhea that lasts for several hours, I get cramps so severe, the pain causes me to vomit. I also can't go to many restaurants because there's nothing on the menu I can have. Now let's talk about travel. As a part of my job as Corporate Administrative Services Manager of a Fortune 500 company, I have to travel monthly from ------------. Because of your position, I am sure you are a frequent traveler and know how bad airline food is. There is seldom a time when the meal does not include a dairy product, even if its a sandwich. The alternate meal is usually fatty. I have tried having the special meals but there has not been one offered that addresses this condition. I can take something on the plane with me when I leave from home, but there's not much I can do for the return trip. Airport food is not conducive to an IBS diet. I also am required to attend many business lunches, dinners, and conferences. Invariably, much of the meal is a problem for me. Also, traveling is hard on the body and even if I eat very carefully, the time changes and exhaustion that accompany traveling often bring on a bout of diarrhea. I felt like a new person when I began taking Lotronex. My doctor did not start me out on two pills, he suggested one, which I did well on. Then he told me he had some patients that only needed half a pill. I then tried that and found it worked well 90% of the time. I take as little medication as possible as most of it doesn't agree with me. I understand your concerns about the drug. But I strongly feel the 500,000 people that have prescriptions have a right to this medication. I think with proper training of the doctors and patients, the few incidents of concern could be eliminated. I don't think everyone who takes it should be punished by a few isolated cases that, with proper monitoring, probably wouldn't have happened. I don't agree with the FDA that because this "condition" isn't life threatening, the drug is not needed. I have episodes severe enough that my colon gets so inflamed I pass blood clots. I would like anyone at the FDA who feels this isn't a significant condition to walk in my shoes for a few months and go through what I do. I can't go anywhere unless I know where the closest rest room is. I have to get up and excuse myself from business meetings and often can't continue with the meetings. I always worry on the airplanes that I will have an episode and not be able to get to the rest room in time. I also wonder if this medication worked on men and not just women if the decision would have been different. Women have been on the short end of the stick in the health care system for years. Women weren't even included in most of the trials for new drugs. I also find it very interesting that Accutane can be on the market although it is showing a strong possibility of causing suicide in its young users. It's OK to let teenagers take a dangerous pill that causes depression deep enough to cause them to commit suicide just so they can have clear skin, but I can't take a pill that lets me live my life outside of a bathroom. And I do not agree with the thought that IBS is a symptom of stress. It that were so why is my problem better on one-half of a pill than on no pill when my stress level is the same. My triggers are fatigue and foods which I don't always have control over, although I do my best because it's no fun living my life on a toilet. Please reconsider your decision on this product and give me back a normal life. If you would like further information, I have included my home address and phone number below or you can reach me by my company e-mail: pahout@beckman.com. Thank you for the time you spent reading this message.