From:
Sent: Wednesday, November 29, 2000 12:03 PM
To: jhenney@oc.fda.gov
Cc: woodcockj@cder.fda.gov; fdadockets@oc.fda.gov
Subject: LotronexTo: Jane Henney, FDAFrom: Kathryn HooverNov.29, 2000 I read with dismay the news reports that Glaxo-Wellcome was "voluntarily" withdrawing the IBS medication Lotronex from the public.I have been on Lotronex for over two months, with no adverse side-effects what so ever.  I have worked closely with my doctor todetermine that my condition was indeed Irritable Bowel Syndrome (IBS), and am under her careful instructions when taking themedication, which has greatly improved my quality of life in the last few months.  I take half the daily dosage recommended,and skip a day if I become in any way constipated, and have had no adverse affects, only freedom from sudden bouts of *severe*cramping and diarrhea that kept me from participating in many activities, or resulted in embarrasing runs to the bathroom, whereI sometimes would have to "hide out" for many minutes.  Lotronex came as a total relief to me, and I hope you will reconsideryour request to Glaxo to withdraw the drug.  Why not suggest instead that they send it back to clinical trials once again, andstudy the dosage level for the lowest effective dose. It seems to me this total withdrawal is beyond what is necessary.  After all, the original birth control pills with their high estrogenlevels caused many strokes and even deaths, until it was discovered that lower levels would work just as well to prevent pregnancy,and would greatly reduce the risks.  The pill was never pulled, just re-designed.  Why not let Glaxo-Welcome do this, whileissuing strong recommendations to doctors to ONLY prescribe Lotronex in appropriate cases (diarrhea and cramps only) andwhile following their patients closely?  Doctors should take some responsibility for what they prescribe and to whom.  Not everyonewith IBS can take Lotronex, but for many it is a miracle drug.  Please reconsider this withdrawal. Thank you for your time,  cc: Janet Woodcock, Director of Center for Drug Evaluation & Research     Dockets Management Branch, FDA