From: Sent: Wednesday, November 29, 2000 12:22 PM To: fdadockets@oc.fda.gov Subject: Lotronex To Whom It May Concern: I cannot object strongly enough to your recommended withdrawal of the IBS drug Lotronex. My 83-year-old mother began taking Lotronex several weeks ago. She has had IBS for four decades. The weeks before she began taking Lotronex were terrifying. She no longer can control her disease. She was losing so much fluid she was forced to visit the ER twice a week for intravenous fluids. She was losing weight and becoming less lucid by the day. She never left the house. She spent hours crying in pain with no relief in sight. Lotronex put the breaks on that process, stopped the diarrhea and -- make no mistake about it -- has prolonged her life. She now digests food like a normal person. She goes to church. She visits her children. She has just begun to overcome her fear of food, which for dozens of years has caused her pain and illness and loss of independence. My research about Lotronex indicates that the drug is a disaster for IBS women whose main symptom is constipation -- and that it has been a miracle drug for people like my mother whose chief problem is diarrhea. Why can it not be restricted for use by those who suffer uncontrollable diarrhea? Why are people like my mother being cut off from the one and only thing that makes a normal life possible for them? Recommendations of "reduced stress" and "high-fiber diets" to control chronic Irritable Bowel Syndrome are unrealistic and insulting to women like her who have lived with pain and virulent diarrhea their entire adult lives. Try curing cancer with a good diet and low stress. Doesn't work, does it? IBS is a disease and it needs a pharmaceutical treatment. Lotronex is the first drug that EVER helped my mother. Our family rejoiced when she ate her first Thanksgiving dinner in years with no painful, dehydrating bouts of diarrhea afterward. Will this be her last Thanksgiving because of your recommended withdrawal of Lotronex from consumers? Please reconsider your recommendation and allow those who benefit from Lotronex to continue taking it. This is not a matter of convenience or even comfort. This will affect length of life for my mother and thousands of people like her. Sincerely, _____________________________________________________________________________________ Get more from the Web. FREE MSN Explorer download : http://explorer.msn.com