From: EXECSEC Sent: Monday, December 11, 2000 9:18 AM To: Dockets, FDA Subject: FW: Docket#OOP-1499/CP1--Lotronex -----Original Message----- From: Henney, Jane Sent: Saturday, December 09, 2000 10:18 PM To: EXECSEC Subject: FW: Docket#OOP-1499/CP1--Lotronex > ---------- > From: Joann Price[SMTP:JAPRICE@POL.NET] > Sent: Saturday, December 09, 2000 10:15:53 PM > To: WoodcockJ@CDER.FDA.gov; JHenney@OC.FDA.gov > Subject: Docket#OOP-1499/CP1--Lotronex > Auto forwarded by a Rule > Dear Drs. Woodcock and Henney, I am very distressed at the FDA's request for the withdrawal of Lotronex. I have several patients whose lives have literally been changed by this medication. My patients have been calling me, very unwilling to give up this medication, since it has made such a tremendous difference in their lives. There is no alternative for these patients. I have nothing else to offer them. Although it is disturbing some patients have had significant adverse reactions and there have been several deaths (although I understand there is no causal relationship established with Lotronex), almost all drugs with current FDA approval have been associated with serious side effects and deaths. Again, THERE IS NO ALTERNATIVE FOR MY PATIENTS. Nothing has helped them in the past. I would like to give you the history on one of my patients, Flora C., a 53 y.o. WF. She has suffered with irritable bowel syndrome since 1974. She reported diarrhea and abdominal spasms lasting the entire morning, everyday, despite the use of Questran and Imodium. This patient could not leave her home in the mornings due to the diarrhea. She could not have taken a daytime job. She could not come to doctor's appointments or do grocery shopping in the morning, etc. When she did schedule an afternoon doctor's appointment, she took Questran and Imodium, and she was still very fearful she would have diarrhea. This patient was almost a prisoner because of the diarrhea and abdominal pain. She has been on Lotronex since May 25, 2000 without any side effects. She recently stated she is "doing extremely well on" Lotronex. She stated, "I HAVE MY LIFE BACK AND I AM SO GRATEFUL". She stated Lotronex "has made all the difference in the world" for her, and she is "now able to live a normal life and leave her house without fear of episodes of diarrhea". Another of my patients, Pat G., a 52 y.o. WF, had severe diarrhea with urgency and episodes of fecal incontinence. Diarrhea awakened her from sleep. She had this pattern for 2-3 years. She had abdominal cramping with the diarrhea. The urgency was so severe, she was fearful of being out of the house, since she would need to get to a bathroom immediately once the urge to defecate struck. She has been on Lotronex since May 12, 2000. Lotronex has been working extremely well for her, with no problems. She stated she absolutely refused to give up the medication she has, and she is asking for an alternative. Lotronex has almost miraculously changed the lives of these women, and I believe this drug should continue to be available to these women and to any other appropriate patient. I believe the FDA has OVERREACTED to the adverse effects some patients have had. Narcotics have killed people in overdoses and have a tremendous addictive potential, as well as many side effects. Anesthetics kill patients. Digoxin patients must be monitored carefully, and some have died due to digoxin. The statins require monitoring of liver enzymes due to potential for liver damage. Many people have suffered bleeding ulcers and death due to NSAIDS. All these drugs, and many more, not only have serious adverse side effects, but cause deaths. Many drugs have precautions in the labeling and require careful monitoring of serum drug levels or liver enzymes or renal function, etc. Yet, all these drugs continue to be approved and used because they have benefits for patients. I believe Lotronex has such significant--even life-changing--benefits for appropriate patients that it should be continued to be approved. There is also no alternative to Lotronex. Perhaps more detailed labeling, both for physicians and for patients, could be instituted. I do not believe the use of this drug should be limited to Gastroenterologists. I am a Gynecologist, and I see women, for whom this drug is appropriate. Many appropriate patients who would benefit from Lotronex never get to a gastroenterologist. (My two patients had suffered for 26 and 3 years, respectively, without ever having seen a gastroenterologist.) Gynecologists who are responsible can read the insert and give the drug only to appropriate patients. Gynecologists can handle this responsibility. I strongly urge the FDA to reconsider the withdrawal of Lotronex. This drug has improved patients' lives in an indescribable way, and there is no alternative. The vast majority of patients who have used Lotronex have had no adverse events. This is a very valuable medication which has made a tremendous difference in the lives of many patients. I urge you, on behalf of the many patients whose lives have been transformed by Lotronex, to give approval for continued use of this medication. Thank you so much for your careful consideration of this matter. Sincerely, Joann A. Price, M.D. 185 Hamilton Avenue Watertown, CT 06795-2431