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Hi I'm new to this board. My husband has suffered with IBS since his early twenties. He has been very resistent to seeking out help due to what doctors have told him about the disease. But recently he has expressed some interest in trying something new. Our lives have become very restricted by his symptoms--mostly diarrhea and cramps. Happens whenever we want to go out and socialize or do anything different from the normal routine.Anyway, we are wondering why the new medications are restricted to women only. Can anyone explain? Also, I saw the news about hypnotherapy and Andy (my husband) is interested. Does anyone know about any therapists in the Seattle area that work with IBS patients?Thanks for any help you can provide.
 

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welcome!The reason why Zelnorm is only for women right now is because the drug company did not recruit enough men to be in the study. I was told by one drug rep that it has proven helpful in men, but they cannot allow it to be for men until they do an appropriate study. I'm not sure about other drugs/therapies that help the symptoms that your husband has because I have the opposite problems, but just keep reading and posting on the board and there will be plenty of people to help. I was lost when I was first diagnosed, and this message board seriously helped me through a lot of my fears and anxieties.Good luck!
 

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The above infor is a little bit off in what happened (why not enough men).There are several phases the drugs much be tested through.Phase I AND Phase II the MUST BY LAW recruite enough men AND woman to be able to do a gender specific analysis. Now for these tests we are talking combined a few hundred people total.At the end of PHASEII you can ONLY BY LAW do Phase III testing for genders that showed a good result in phase II.Now most drugs are not different in men and woman, but the law was changed in the mid 1990's to REQUIRE this gender analysis because sometimes it makes a BIG difference (not just in IBS drugs....most drugs on the market were never tested in woman so it is hard to know if they really work or not scientifically).Both Lotronex and Zelnorm in the PHASE II analysis worked only in the woman in the trial.This means the COULD NOT recruit men into Phase III trials except for looking at why the genders are different.With Lotronex there is some evidence that for some men it may act the same way as it does in woman, it is just the percentage is so low that in a population you can't tell the difference between the Lotronex and Placebo groups. Zelnorm in the Phase II trials had a tendancy to make men worse than placebo, and I don't know how much they have done gender work on it.What they do in the various phases.Phase I. MEN AND WOMAN. Healthy volunteers to check dosage (safety only) and how drug is metabolized, etc by human beings. I know Zelnorm was the same men and woman in the Phase I trials. Dozens of peoplePhase II. MEN AND WOMAN. People with the disorder to see if anything happens, and what dose range seems to be effective. Gender analysis must be done. Hundreds of peoplePhase III. Gender based on Phase II results. Checking the dosages are safe and effective and analyze for side effects. Thousands of people.If you lump the whole thing together not that many men were tested, but ENOUGH were tested in the early phases to show that they were not likely to be effective for men.K.
 

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ZELNORM ORALUses & Dosage Uses from First Databank Labeled Uses Constipation Predominant Irritable Bowel Syndrome Unlabeled Uses Uses from AHFS DI� Constipation-Predominant Irritable Bowel Syndrome in WomenTegaserod is used for the management of irritable bowel syndrome (IBS) in women whose predominant intestinal symptom is constipation.Safety and efficacy of tegaserod in the management of constipation-predominant IBS were established in 3 multicenter, double-blind, controlled studies in women (mean age: 43 years) who met Rome I criteria for IBS symptoms of abdominal pain, bloating, and constipation for at least 3 months prior to initiation of the studies.In these studies, constipation was characterized by the presence of at least 2 out of 3 symptoms (less than 3 bowel movements per week, hard or lumpy stools, straining at defecation) occurring at least 25% of the time over a 3-month period.Following a 4-week baseline period, for 3 months, patients received a fixed-dose regimen of tegaserod (6 mg twice daily) or placebo in 2 studies or, alternatively, a dose-titration regimen of tegaserod (up to 6 mg twice daily) or placebo in the third study.(1) After 1 month, 31�35% of patients receiving tegaserod 6 mg twice daily achieved response (considerable or complete relief for at least 2 weeks or some relief for all 4 weeks, of the month) compared with 17�22% of those receiving placebo,while after the third month 39�44% of patients receiving tegaserod 6 mg twice daily achieved such response compared with 28�39% of those receiving placebo.Safety and efficacy of tegaserod maleate in men have not been established to date.Dosage and Administration from AHFS DI� GeneralTegaserod maleate is administered orally twice daily.Because food may decrease plasma concentrations, lengthen the time to achievement of peak plasma concentrations, and decrease oral bioavailability of tegaserod,the manufacturer recommends that tegaserod maleate be taken before meals.Dosage of tegaserod maleate is expressed in terms of tegaserod.Special PopulationsNo special population dosage recommendations at this time. Lotronex Back on Market Despite Drug-Related DeathsLaurie Barclay, MD Medscape Medical News 2002. � 2002 Medscape June 11, 2002 � Despite being linked to at least 4 deaths and nearly 200 serious adverse gastrointestinal events after only 8 months on the market, Lotronex (alosetron hydrochloride) is again approved for severe cases of irritable bowel syndrome (IBS). Although the U.S. Food and Drug Administration (FDA) has imposed dramatic restrictions on its use, some question the wisdom of having manufacturer GlaxoSmithKline (GSK) in charge of the risk management program."This is a classic case of the fox guarding the hen house," Larry Sasich, PharmD, MPH, a pharmacist and research analyst with Public Citizen's Health Research Group, says in a news release. "GSK has a huge stake in this drug and wants it to succeed. The company should not be overseeing the patient safety program."After FDA approval of Lotronex in February 2000, reports followed of 84 cases of ischemic colitis and 113 cases of serious complications of constipation by March 8, 2002. Of the 84 patients with ischemic colitis, 54 required hospitalization, 2 received blood transfusions, 11 underwent surgery and 2 died. Of the 113 cases of serious complications of constipation, 83 patients required hospitalization, 2 received blood transfusions, 34 underwent surgery and 2 died.Although GSK voluntarily withdrew Lotronex from the market in November 2000, the FDA's Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Subcommittee of the Advisory Committee for Pharmaceutical Science recommended on April 23, 2002, that access to Lotronex be restored through a restricted distribution and use program."This is the first time that a drug has been withdrawn from the market and has returned," Victor Raczkowski, MD, FDA's deputy chief of gastrointestinal drugs, tells WebMD. "We didn't know what the risk factors were to predict which patients would get ischemic colitis and which wouldn't. That is still the case. However, all prescription drugs have risks associated."On June 7, the FDA announced the approval of a supplemental New Drug Application permitting marketing of Lotronex with restrictions. The indication is narrowed only to treatment of women with severe, diarrhea-predominant IBS refractory to conventional IBS therapy. Estimated risk of ischemic colitis is one case in every 350 women who take Lotronex for six months, but the risk for women who use the drug for longer periods is still unknown. "Our goal with this program is to try to put mechanisms in place to assure that only the most severely affected women with IBS diarrhea are affected," Raczkowski says. "These patients might be willing to accept the risks. The risk-management program is a very important component."In an attempt to reduce risk, the Lotronex risk management program mandates the following: GSK will establish a program for Lotronex to enroll prescribing physicians who report that they are qualified to diagnose IBS and to manage ischemic colitis, and that they understand the risks of using Lotronex. These physicians must promise to educate patients about the risks, to have them sign a patient-physician agreement, and to provide them with a copy of the FDA-approved medication guide.However, Public Citizen points out that no one is required to verify the doctors' qualifications or to evaluate whether patients have been properly informed of the risks of Lotronex treatment, and that GSK will monitor the risk management program while reporting on the prescribing and actual use of Lotronex. "There are numerous checks and balances in place to ensure patient safety," Raczkowski says, while acknowledging that involved physicians must be vigilant to detect complications and report them promptly. "We'll be monitoring adverse events very closely."According to FDA restrictions, pharmacists can fill only those prescriptions that display a prescribing program sticker affixeeed by an enrolled physician, and they must give patients a copy of the FDA-approved medication guide every time they dispense the drug. Enrolled physicians must report serious adverse events to GSK at 1-888-825-5249 or to the FDA at 1-800-FDA-1088.When asked at what point the FDA would withdraw Lotronex, Raczkowski explained that rates of ischemic colitis and constipation similar to those already reported would probably still be acceptable: "If we do see something beginning to occur, we anticipate working closely with GSK and possibly revisiting with the advisory committee to evaluate the situation. If we do see something we intend to get actively involved."Eric Carter, MD, vice president of gastrointestinal clinical development for GSK, tells WebMD he doesn't really know how many patients will take Lotronex: "Our hope is that there is a significant number of patients who might benefit." Another caveat offered by Public Citizen is that the recommended dose of Lotronex is now 1 mg per day, which was not significantly more effective than placebo in premarketing studies. In 12% of the first 70 cases of ischemic colitis reported to the FDA, the patient was on the 1-mg/day dose approved for the new marketing plan. Early trials also showed a four-fold increase in constipation at this dose compared with placebo, severe enough to cause study termination. Rather than approving a supplemental NDA, Public Citizen suggested that the FDA should have limited the drug to research status for women who had previously used it without adverse effects. Research status would require tight controls on use and documentation of efficacy and safety, rather than leaving most of the monitoring to the manufacturer."We are quite fearful for patients," Sasich says. "Unfortunately, the FDA's action will almost surely lead to more injuries and possibly deaths associated with this drug."Reviewed by Gary D. Vogin, MD
 
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