# Public Citizen: New Drug for Irritable Bowel Syndrome Raises Safety Concerns



## Jeffrey Roberts (Apr 15, 1987)

March 22, 2001New Drug for Irritable Bowel Sydrome Raises Safety Concerns, May Not Be EffectivePublic Citizen Petitions FDA to Stop Drug From Reaching MarketWASHINGTON, D.C. - A prescription drug that is on the verge of beingapproved by the Food and Drug Administration (FDA) should not be allowed onthe market because it raises serious safety concerns and may not beeffective, Public Citizen said today.The drug, tegaserod (called Zelmac by its maker, Novartis Pharmaceuticals)is designed to treat constipation-predominant Irritable Bowel Syndrome(IBS). However, the drug was associated with a three- fold increase in therate of ovarian cysts in women in clinical trials compared to a placebo.Five women were hospitalized and had surgery, Public Citizen noted in apetition to the director of FDA's Center for Drug Evaluation and Research,Janet Woodcock. Studies in rats also showed that the drug unequivocallycauses ovarian cysts. A copy of the petition is available at http://www.citizen.org/hrg/publications/1561.htm.[/URL] Further, it is unclear if the drug is effective, the petition notes. None ofthe three pivotal trials demonstrated efficacy according to the originalprotocol. Even after Novartis altered the parameters of the trial, loweringthe threshold for efficacy, just one of the two remaining trials showed someefficacy, and that was modest. And while tegaserod is to be marketed forconstipation-predominant IBS, many of the patients in the trials were notconstipated, the petition says."The FDA would be foolhardy to approve this drug," said Dr. Peter Lurie,deputy director of Public Citizen's Health Research Group. "Irritable bowelsyndrome is not a life-threatening condition. The risks of letting this drugon the market are simply not worth the benefits, if any exist."Added Dr. Elizabeth Barbehenn, research analyst with Public Citizen, "If theFDA approves this drug, it may well have to be withdrawn because of the highprobability of seeing more cases of ovarian cysts once the drug reaches theless-carefully monitored and less healthy population at large."The petition reminds the FDA of Lotronex, a drug that also was designed totreat IBS (diarrhea- predominant type) but had to be pulled from the marketshortly after being approved because of serious adverse effects also knownprior to approval.###Public Citizen is a nonprofit consumer advocacy organization based inWashington, D.C. For more information, please visit www.citizen.org.


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## Pisces65 (Jan 15, 2001)

There they go again. Ruining it for us IBS Suffers!!!!!!!!


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## Jeffrey Roberts (Apr 15, 1987)

Given that the FDA is working with GlaxoSmithKline on restoring Lotronex to the marketplace, I suggest that Public Citizen's track record on having any effect on discrediting new IBS drugs is going to be 0 for 2.I believe that Public Citizen is not in touch with what the IBS patient is feeling. Their scare tactics in their press releases do nothing more than discredit an already tarnished reputation in the eyes of the IBS Community.I do not believe that Public Citizen has all the facts on Zelmac and I believe their petition will most certainly fail.Jeff[This message has been edited by Jeffrey Roberts (edited 03-22-2001).]


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## Guest (Mar 23, 2001)

I think the FDA should ban "Public Citizen." Afterall, it's been known to cause heartache.


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## TheDude0306 (Mar 10, 2001)

I read the postive post about Zelmac drug, and I am a male and I want this drug.When I read the postive news that the drug would be approved by the first half of 2001, I started to cry, for reasons of relief that maybe something will be able to help me, and for reasons that I am afraid that it won't work, and for reason that it still may never make it to the market.I have been living with CRONIC IBS-C since the age of 17. I haven't had a life since 17. Haven't dated since then, now at age 26, all of my friends have grown up, married and moved on with there lives.Im the only one left, just existing feeling like complete *HIT everyday of my miserable life. You wanna hear my daily schedule? Sunday night a few hours before bedtime I posion myself with usually 3 to 5 ducolax laxatives, followed by 3 to 4 TABLESPOONS of perdiem with SENA. I go to sleep around 12AM right when I start getting terrible pains in my already BLOCKED up stomach.By 2AM I usually start having horrible nightmares in my sleep, because of the pains in my stomach. So on and off sleep throughout the night. Usually at 6AM the pains are so bad that I get up and s**t my brains out.The rest of the day tired and my stomach is so sore it feels like someone punched me in the stomach a million times. In the afternoon I start to feel better, my stomach now empty and not constipated feels pretty good. But I worry all day, I worry because anything I eat I know will make me sick. I will eat, get bloated feeling and start to worry how on earth am I going to digest what I just ate.The next day I go to my pathetic job, SICK because I am constipated. I cannot take any harsh laxatives, otherwise I would be to sick to work. So I work all day with gas pains in my stomach, farting and feeling just plain horrible. Still having to work the next 2 days in a row, I still cannot take any laxatives, so I desperatly try to eat foods that will help me go.But now in the constipated state I only get more gassy in my stomach and feel more and more sick.By day 3 at the job I am dying. I am wishing the last 3rd day of my work week away, so I can go home and POSION myself with a bombshell of laxatives.Then the whole thing starts over. Going to sleep waking up sick in the middle of the night with cramps and pains from the laxatives, horrible nightmares, getting disturbed sleep etc.Imagine what its like to constantly worry if and when you may go to the bathroom. I look at a saltine cracker in horror, knowing that it will constipate me so fast.Working a part-time job, making horrible money, just so I can stay home and posion my body with chemical laxatives. Don't tell me to try over the counter drugs/mixes or to eat the right foods. Nothing works I have tried every product in the world except ZELMAC! I must try this drug, if it doesn't work, well then I will continue to suffer and wait and hope, but if after waiting all this time, that I don't get to atleast try the drug to see if it works, I swear to GOD that it will only be a matter of time before I kill myself.The quality of my life, is 0. I also have IC a severe and cronic condition with my bladder. Living with both of these diseases is to much for me to handle. I have been suffering with both for 9 YEARS and I am finally at the end of my rope.The only time I get some relief from my bladder's CONSTANT PAIN is when I have a bowel movement and empty myself out. So if Zelmac could make me go the bathroom on a somewhat normal basis, theres a good chance that I may be able to live some sort of freakin life already.I cant beleive and I quote :"The FDA would be foolhardy to approve this drug," said Dr. Peter Lurie,deputy director of Public Citizen's Health Research Group. "Irritable bowelsyndrome is not a life-threatening condition. The risks of letting this drugon the market are simply not worth the benefits, if any exist."Well im a male so I dont have to worry about the ovarian cyst problem that this drug may cause.Jesus CHRIST atleast let men try it..This disease is LIFE THREATING!!!!!! You can only go so long suffering in life like I am, before you do something drastic.I have always had a good life. Growing up in a middle class family with a great mother and father and sister. Lots of friends and good times in my younger years, never problems with drugs or anything. A very mentally stable person.Im a very nice person as well. I love animals and there one thing in my life now that keeps me somewhat sane.The depression of being sick so long is taking it's toll on me.Within the last 3 years of being sick I have started drinking heavly. I have always been a somewhat social drinker, but now my life focus's around getting drunk. Atleast it helps to forget about my sickness.As I said I never have done drugs in my life, and always promised myself I would never do so.Recently I have been dabbling in marijuana, and although I worry about ruining my health from it, I also remember how sick I am, so I figure why NOT.Im disapointed in myself for starting to use the drug, but it makes you feel good, and that is something needed when you always feel bad.Thanks for reading my LONG RANT. You people understand were I am coming from.I dont have all my eggs in one basket for zelmac. I want to atleast have a chance to try and use this drug, even if it may have adverse side effects, HELL if they told me my left arm would fall off, but I would feel 100% normal I would still take the drug.PEACE


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## Rose (Mar 25, 1999)

To the Dude?? Are you Damon??? If you are, I am so sorry you are still having a terrible time. I haven't seen you posting in a long time. I had hoped you were feeling better. ------------------"Remember To Stop and Smell the Roses"Rose (C-type)


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## Kathleen M. (Nov 16, 1999)

To the Dude. you may want to talk to your doctor about Miralax. Someone just posted a nice sucess story using that over on the main self-help board.K.------------------I have no financial, academic, or any other stake in any commercial product mentioned by me.My story and what worked for me in greatly easing my IBS: http://www.ibsgroup.org/ubb/Forum17/HTML/000015.html


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