# 8/24 - FDA Creates Medication Guide for Lotronex



## JeanG (Oct 20, 1999)

The URL for this article is: http://www.fda.gov/bbs/topics/NEWS/NEW00734.html HHS NEWSU.S. Department of Health and Human Services P00-17 FOOD AND DRUG ADMINISTRATIONFOR IMMEDIATE RELEASE Print Media: 301-827-6242August 24, 2000 Broadcast Media: 301-827-3434 Consumer Inquiries: 888-INFO-FDA FDA CREATES MEDICATION GUIDE FOR LOTRONEX Health Professional Labeling Revised to Help Manage RisksThe Food and Drug Administration (FDA) today announced the development of a Medication Guide (FDA-approved patientlabeling) to help ensure that women using the prescription drug Lotronex (alosetron hydrochloride) for treatment of thediarrhea-predominant form of irritable bowel syndrome (IBS) will understand the rare but serious risks of Lotronex and howthey can recognize those risks and take early action to prevent serious harm. These risks include complications fromconstipation and the risk of ischemic colitis, a serious complication caused by reduced blood flow to the intestines.Information for health professionals who prescribe Lotronex has also been updated. Lotronex is a drug with a demonstratedbenefit in the treatment of diarrhea- predominant IBS, which can be severely incapacitating. FDA believes that the benefits ofLotronex outweigh its risks when it is used according to the instructions in the Medication Guide, which reflect the revisedprofessional labeling."Today's actions are an important milestone in enabling consumers as well as healthcare professionals to better manage the risksthat are inherent in even very beneficial drug treatments, " said FDA Commissioner Jane E. Henney, M.D. "By providingimportant new safety information about a drug through a Medication Guide to patients, as well as updating the professionallabeling, we can better assure that an effective drug can be used safely."IBS is a functional abnormality of the gastrointestinal tract that is estimated to affect up to 15% of the U.S. population. Peoplewith this condition experience chronic or recurrent abdominal pain, and irregular bowel movements including diarrhea,constipation or both. Patients may experience the sudden, urgent need to go to the bathroom or straining when they have abowel movement. IBS is two to three times more common in women than men.Lotronex is the first drug to have a Medication Guide under regulations that became effective in 1999. A Medication Guidecontains FDA-approved information, written especially for patients, that pharmacists are required to distribute with productsFDA has determined pose a serious risk, for which patient labeling can help prevent that risk. In some patients, the risksassociated with Lotronex led to hospitalization or surgical procedures not normally associated with IBS.FDA determined that a Medication Guide is needed for Lotronex because patients play a very critical role in managing the risksof the product. The Medication Guide instructs patients who become constipated while taking Lotronex to call their doctor rightaway. Patients are instructed to stop taking Lotronex immediately and to contact their doctors if they get severely constipated,have worsening or bothersome constipation with increased abdominal discomfort, or notice signs of ischemic colitis such asnew or worsening abdominal (lower stomach area) pain, bloody diarrhea, or blood in their bowel movements. These may beearly signs of serious side effects associated with the use of Lotronex.The Lotronex Medication Guide, which will be attached to every bottle of the drug, also gives patients the following guidance: Before starting Lotronex, a woman should discuss with her doctor how troublesome her IBS symptoms are, and the possible benefits and possible side effects of Lotronex, to decide if Lotronex is right for her; Lotronex is only for women with IBS who have diarrhea as their main symptom (diarrhea-predominant IBS). Women who have constipation as their main IBS symptom should not use Lotronex; Because Lotronex does not cure IBS or work for everyone, women are advised to stop using Lotronex and to tell their doctors if their IBS symptoms do not improve within four weeks of starting the drug; and Lotronex has not been shown to help men. The updated labeling for health professionals states that Lotronex treatment should not be started when women are constipated;and it informs prescribers that Lotronex is now contraindicated in women with: a history of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions; a history of ischemic colitis; active diverticulitis; or current Crohn's Disease or ulcerative colitis, or a history of such a disease. Between the approval of Lotronex on February 9, 2000, and June 1, 2000, FDA received seven reports of seriouscomplications of constipation. This resulted in the hospitalization of six patients, three of whom required surgery. While 25-30%of patients taking Lotronex in the pre-approval clinical trials had experienced constipation, FDA had received no reports ofserious complications before approval.During the same time period, FDA received eight reports of ischemic colitis in patients taking Lotronex. This resulted in fourhospitalizations, four endoscopic procedures and no surgeries. In addition, four cases of ischemic colitis were reported in theclinical studies of Lotronex before approval. All twelve patients with ischemic colitis recovered without serious consequenceswhen Lotronex was discontinued.Lotronex's sponsor, GlaxoWellcome of Research Triangle Park, N.C., is issuing a "Dear Health Care Professional" letter toinform prescribers of the labeling changes. GlaxoWellcome is also issuing a "Dear Pharmacist" letter to inform pharmacists oftheir obligation to provide patients a Medication Guide with each Lotronex prescription filled.Today's announcement follows a detailed review of the adverse event reports and risk management recommendations made byFDA's Gastrointestinal Drugs Advisory Committee at a public meeting on June 27.The FDA encourages health care providers to report any cases of serious constipation or of ischemic colitis to FDA'sMedWatch program by calling 1-888-INFO-FDA or by logging onto FDA's MedWatch site at www.fda.gov/medwatch/safety/2000/safety00.htm#lotron. For further information on this subject, go to the Center for Drug Evaluation and Research's Lotronex Information Page on thisWebsite. FDA News Page | FDA Home Page Office of Public AffairsHypertext uploaded by clb 2000-AUG-24.[This message has been edited by JeanG (edited 08-25-2000).]


----------



## moms777 (Jan 29, 2000)

Thanks Jean for this info. My mom just called from Florida to tell me that there is a big article in her paper about it. She said that some women on Lotronex require surgery. Yikes, I'm glad I was only on it for a few days.


----------



## Guest (Aug 25, 2000)

Thanks for posting this, Jean. I guess I am one of the few people that still aren't afraid of Lotronex. Taking any kind of medication requires common sense. If a person becomes constipated or has pain, stop taking the med for a while or take a partial amount. I am so glad they aren't pulling it off the market and that they are taking the route of education. It is everyone's responsibility to education themselves on the medications they take.


----------



## WellWisher (Dec 15, 2004)

Good response, Joanie!


----------



## JeanG (Oct 20, 1999)

I feel the same way, Joanie. First, the doctor should make sure he/she is prescribing the right medication for the condition. Then the patient should read the literature given with the meds to see what the side effects are. That way if something happens, say constipation, they can immediately call the doc and see what should be done.I always ask the doc, read the handout with the meds, check the internet, and sometimes call a pharmacist. If I don't develop side effects, I don't worry, but I still keep an eye out for any changes.JeanG


----------



## cheryl (Mar 1, 1999)

Hi Jean,I read the Lotronex warning article last night at AltaVista. I was worried about all the people on this board who take it. Thanks for posting this educational piece. Joanie,You're a smart lady! Good for you!


----------



## Miss Patience (Oct 23, 1999)

I'd just like to echo what Joanie and Jean have said. I've seen a few folks make "phew, thank goodness I didn't take Lotronex" postings in a tone that sounds like they dodged a bullet. ALL MEDICATIONS have serious risks. You can develop hepatitis from anti-depressants. People die from taking certain antibiotics. Even aspirin causes problems for some people. We need to use common sense and NOT go into panic mode over every possible side effect...that just feeds into the "nanny mentality" of "advocacy" groups, such as the one that plans to petition to have Lotronex removed from the market. Everything in life has risks and rewards. I just wish people wouldn't get so "chicken little" over every warning.Colleen


----------



## Guest (Aug 26, 2000)

Miss Patience is on the right track! My 18 year-old daughter had always been able to take penicillin up until about 6 months ago when she had a horrible reaction. We had to stop her on the meds and call the doctor. So even people that have been able to successfully take certain medications can, for no apparent reason, have adverse reactions at some point in their life. Every medication should be monitored.


----------



## salledell (Aug 31, 2004)

Joanie:My husband alerted me to the dangers of Lotronex so I went to www.publiccitizen.org to read their petition to withdraw the drug from the market. Since Lotronex has been a godsend for me and I have never had a constipation problem, I wish to have the drug available to me when I need it in the future. Immodium and Lomotil were of no use in treating bouts of severe watery diarrhea, of which one episode landed me in the emergency room for rehydration.I sent Public Citizen an e-mail to tell them that they do not represent me and that I wish to keep the drug available.Several men died from heart attacks or strokes after using Viagra, but that certainly didn't keep other men from enjoying the benefits of the drug.And constipation is definitely not one of the symptoms for which Lotronex is prescribed.


----------



## Guest (Sep 3, 2000)

I agree not to take it off the market. This is the first product I have tried that worked! Dee


----------

