From: EXECSEC Sent: Wednesday, December 06, 2000 8:13 AM To: Dockets, FDA Subject: FW: LOTRONEX -----Original Message----- From: Henney, Jane Sent: Wednesday, December 06, 2000 8:10 AM To: EXECSEC Subject: FW: LOTRONEX > ---------- > From: - > Sent: Wednesday, December 06, 2000 8:04:10 AM > To: JHENNEY@OC.FDA.GOV > Subject: LOTRONEX > Auto forwarded by a Rule > > > Dear Doctor Henney: I am writing to let you know how incredibly upset I am about the removal of LOTRONEX from the market. This drug gave me my life back! For over 15 years I suffered on a daily basis. Six months ago I was put on LOTRONEX and immediately I felt the difference. I was a whole person again…I felt great! This drug empowered me to live a normal life, something I had not done in many many years. I can’t believe it’s being taken away from me! Although the drug was prescribed for my irritable bowel symptoms, the major benefit that I experienced was that my migraines virtually disappeared. Life with migraines is a horrible nightmare. I was averaging 10 IMITREX shots a month before LOTRONEX. When I started taking LOTRONEX, my IMITREX usage went down to 1 shot a month--a wonderful side effect of the drug! I felt so good, better than I have in over 15 years. My debilitating migraine symptoms didn’t come when I took the LOTRONEX. It was wonderful. And, the irritable bowel symptoms were greatly reduced. When I did have constipation I took a magnesium supplement (250mg-750mg) as needed. It worked beautifully. Isn’t there some way this drug can be returned to the market? Can it be reformulated with magnesium to help with the constipation? Is it possible for some people who had great success with the drug to keep on getting it if their doctor okays it? My doctor said he would sign any paperwork for me to keep getting LOTRONEX. I have not had LOTRONEX for 4 days now and I feel significantly worse. My body is in pain, my head feels swollen, and my spirit is crushed. I feel like my health has been ruined- and my life taken away from me. This was a wonderfully effective drug. I don’t know where to turn now. Can you help me? Is there a way for me to continue taking LOTRONEX? Anything you can do will be greatly appreciated Thank you,