Zelnorm alternatives following recent recall

Austin Kirk

By Austin Kirk
Posted May 14, 2007

ADD YOUR COMMENTS 21

Zelnorm was recently removed from the market after research linked the drug to an increased risk of heart attacks, strokes and other cardiovascular events.  Some individuals with constipation predominant IBS (irritable bowel syndrome) have been seeking Zelnorm alternatives to relieve their symptoms.

>>INFORMATION: Zelnorm Recall

In July 2002, the FDA approved Zelnorm (generic tegaserod maleate) for use in the United States.  The drug was intended to relieve symptoms of IBS with constipation by increasing movements of stools through the bowels.  However, it has never been very effective and when reports surfaced that Zelnorm side effects could cause serious and potentially fatal cardiovascular problems, the FDA requested that the drug be removed from the market on March 31, 2007.  It was determined that the risks outweighed the limited benefits of the drug.

Shortly after FDA approval, many experts and advocacy groups criticized the decision to approve Zelnorm since there was little proof that it relieved constipation any better than fiber supplements and other alternatives.  In Europe, Zelorm was rejected on two separate occasions.

Clinical studies have shown that Zelnorm provides no benefit for men with IBS-Constipation, and only 5% to 11% of women fared any better when taking the drug.  Therefore, many long-term sufferers have already been searching for an alternative to Zelnorm.

On various websites and internet forums, those with constipation predominant IBS have indicated that some of the following treatment alternatives have shown improvement of symptoms.  This information is not being provided as medical advice, but rather as a summary of information which some have indicated helped them.  None of the following should be tried without first consulting with your physician to discuss the benefits and risks associated with each Zelnorm alternative.

ALTERNATIVES FOR CONSTIPATION

  • Milk of magnesia – a fairly mild laxative which is gentle on the stomach
  • Miralax – a powerful laxative, which is referred to as an osmotic laxative since it draws water into the bowel
  • Amitiza – medication which is designed for chronic constipation
  • Kristalose – a prescription laxative which can treat

NATURAL ALTERNATIVES

  • Magnesium Supplements – magnesium oxide and magnesium citrate
  • Acacia – organic soluble fiber which can help relieve constipation
  • Fennel – fennel seed tea can be beneficial for bloating
  • Peppermint – enteric coated peppermint oil has been reported to relieve and prevent abdominal pain, bloating and discomfort
  • Probotic foods – foods which could help calm IBS include sauerkraut, yogurt, cheese, buttermilk, kefir, soy sauce, tofu and unpasteurized beer
  • Hypnotherapy – gut-directed hypnotherapy can address the underlying pathology of bowel dysfunctions and improve symptoms

ZELNORM LAWYERS

The Zelnorm lawyers at Saiontz & Kirk, P.A. represent individuals who have suffered a heart attack, stroke or ischemic colitis after taking the IBS drug.  The FDA has indicated that users looking for a Zelnorm alternative should speak with their healthcare providers.  New treatments should always be reviewed with your physician to discuss potential benefits and side effects.

If you, a friend or family member wish to speak with an attorney about your legal alternatives and Zelnorm lawsuits which are being pursued, request a free consultation and claim evaluation.

>>REQUEST A ZELNORM LAWSUIT EVALUATION<<

21 Comments • Add Your Comments

  • Jean Burke says:

    I used Zelnorm for 1.5 years with miraculous results in treatment for a megacolon = chronic intractable constipation. My GI physician proposed treatment with Zelnorm saying that it would ONLY work IF the constipation arose from a problem with the colonic nervous system, i.e. if the nervous system in the colon was not transmitting messages effectively. He said it was only effective in 1 of 4 patients. It was a wonder drug for me. Nothing else worked – not fiber, not a vegetarian/vegan diet, not naturopathy or homeopathics, not colonic irrigation, not even laxatives. I was ready to say that surgical removal of the colon was the only way to go when my physician told me about the “new drug” Zelnorm, and it made my life liveable.

    You are misrepresenting the situation when you say that Zelnorm was “never very effective.” The target population was always understood to be small. In addition, my understanding is that only patients with risk factors for CV problems were adversely affected by this drug, which means that patients WITHOUT risk factors could probably take this drug safely and with GREAT BENEFIT.

    I am a Paralegal working in Canada in the field of personal injury. I have high regard for lawyers as guardians of the rule of law and fair treatment of persons injured by negligence, and through no fault of their own. You are giving lawyers a bad name by misrepresenting the facts about use of Zelnorm, as you have done on this web page. Who are you seeking to beneft?

    Posted on May 15, 2007 at 10:33 pm

  • sheila gay says:

    I have been on zelnorm, for a period of 8 or 10 years. I now have IBS from takeing zelnorm. I have adominal cramping, from eating certain foods.I stay bloated all the time. I have contipation problems. which zelnorm did not help.I uaually go to the bathroom about once every 2 weeks. I now have crohns disease.And colitis of the bowels. I also experince chest pains. I have been to my DR. for this problem, and he told me to flush the zelnorm down the toilet. I never had any of these problems, until I started taking Zelnorm.

    Posted on May 16, 2007 at 11:06 am

  • Austin Kirk says:

    Ms. Burke, Thank you for sharing your experiences. Certainly you are not alone as an IBS sufferer who found Zelnorm effective in treating your symptoms. However, the clinical studies have demonstrated that it is effective for a very small number of users (approximately 5-11% of female patients). In addition, wide promotion of this medication by the manufacturer has resulted in many users receiving the drug off-label, even though it is only intended for IBS with constipation.

    The FDA has recognized that there is a population for whom Zelnorm may be an acceptable treatment alternative, and they have indicated that it is possible the drug could be reintroduced in the future for a much more limited and controlled population to reduce the risk of heart attack, stroke and death associated with the drug. At this time they have found the risk of Zelnorm side effects outweighs the very limited benefits the drug provided, which is whyit has been removed from the market.

    Our office has been contacted by many Zelnorm users who did not have the same experiences as you, many of whom suffered heart attacks, strokes and ischemic colitis which could have been avoided if the manufacturer had warned of the danger.

    Posted on May 17, 2007 at 8:37 pm

  • Tanya Francis says:

    I have to agree with Ms Burke. I have severe IBS with constipation effecting my entire digestive track. I went for months with other medications where I was throwing up my bowel and had pain worse then when I had 2 kidney stones. Zelnorm was the only thing that worked for me and allowed me to start being able to function daily. I understand that some people have had problems with it but that happens with any drug. I can’t understand why it is not made available for those of us that have had no problems after a year and half of taking it as long as we understand the possible risks. For myself the risk is better then what I have had to go through on a day to day basis since Zelnorm was taken off the markey last year.

    Posted on May 2, 2008 at 1:56 am

  • Demari Monico says:

    I am a strong supporter of Zelnorm. I suffered from IBS with constipation and it was dibilitating on a number of levels. Since this drug has been removed from the market I have spent each day dealing with the day to day struggles that this condition brings. I have to keep two wardrobes to accomodate the ever changing bloating that can be so extensive it may require me to wear maternity clothing. I agree with Ms. Francis & Ms. Burke. The risks associated with this medication are not great enough that I want to leave this condition untreated. Those 5 – 11% of women may not seem like a significant number to the FDA but if you ask those women what kind of results they had that 5 – 11% may seem a bit more real as you realize how this medication changed their life.

    Posted on June 10, 2008 at 9:47 pm

  • theresa says:

    I am a strong supporter of Zelnorm. With just about every medicine on the market there are some adverse side-effects. It would be great if one drug worked for 100% of the population, but unfortunately in the real world that is not the case. I wonder what percentage of the world are helped with first generation drugs, and why they had to develop second and third generation drugs, and are still working to develop further drugs in the same categories. Would you say to those that Penicillin helps, but cause a large percentage of the population have side effects it is not longer available. I think not, rather i know not. This drug should be remarketed with stricter guidelines. Simply state what the risks are and let the person and their doctor take the risk. Me personally the benefit greatly outweighs any risk there they could be, even death.

    Posted on December 27, 2008 at 6:28 pm

  • pamela says:

    Zelnorm was a miracle drug for me, eliminating constipation, bloating, and gas. Replacements cause nausea and/or do not work as effectivley. Recall was simply Novartis’ response to FDA request for further testing – this was a monetary decision, not a safety decision. I am proof that when Zelnorm worked, it worked wonders. I’d go back on it in a second if it was made available. The change in my life and physical well-being was miraculous. Interesting that a drug that was primarily effective for women is considered one not worth additional testing.

    Posted on January 23, 2009 at 4:20 pm

  • Lindsay says:

    I have dealt with constipation my entire life and at the age of 25 began to experience severe abdominal pain and bloating. After many testing procedures with a gynocologist and a GI specialist they concluded a diagnoses of IBS w/constipation. The abdominal pain was severly affecting my quality of life so I was then introduced to Zelnorm and after two weeks the pain, bloating, and constipation miraculosly disappeared. Several times I tried to stop taking Zelnorm however the IBS symptoms would come back just as severe, so my GI presribed it for me for the long term. My life was normal again….after two years on Zelnorm I became top sales rep for my company and was acheiving the dreams and goals I set for my life. Then the day came when they recalled Zelnorm and everything changed. Since Zelnorm was made unavailable to me I have taken so many different types of medications, I’ve had multiple spinal block procedures attempting to relieve the abdominal pain, and most recently inpatient surgery (which was horrible). Still, nothing works except Zelnorm (tegaserod maleate) and my quality of life is just getting worse. I don’t understand why a medicine that helps me and so many others like me is virtually impossible to get. All the time I see commericals for medications that have so many side effects and risks and I feel so cheated. I have tried EVERYTHING!!! If you’re still reading this incredibly long sobb story….and you know of anything that works like Zelnorm. Better yet….if anyone knows if the FDA will ever hear the voices of others in my situation and give us access to a drug that means so much to our quality of life…..

    Posted on February 10, 2009 at 6:20 pm

  • J.Jones says:

    I totally agree with the fact that all drugs are not for everyone, but Zelnorm was for me!! However, i do know, that i have tried everything and at this point, I’m miserable. My quality of life has/is deminishing daily. Pain and discomfort keeps me from performing daily functions. Bloat keeps me from wonting to, well get out of bed, since my pj’s are the only comfortable clothes i seem to have. I have been taking Protonix since the recall and at first it helped with the pain. I unfortunately tried the generic and now, neither works for me. Putting that drug back on the market would restore the quality of life i once had. Amatiza, tried it. Horrible stuff!! Youll need to wear a diaper with that one. Now thats something you can recall. They want perform surgery so i have no choice but to live like this.

    Posted on March 19, 2009 at 3:11 pm

  • sasha says:

    I too wish Zelnorm was available. I have tried everything. Even being a Vegan. I guess I just need to eat raw veggies for the rest of my life. I have had numerous tests done from the GYN and GI doctor. I am very miserable and want to be my old self again.

    Posted on July 30, 2009 at 6:48 pm

  • Mo says:

    I wish Zelnorm would come back, nothing worked for me except it.

    Posted on August 7, 2009 at 2:55 pm

  • Kay says:

    After years of suffering from constipation, Zelnorm was given
    to me,,,I had a new life, felt great, looked great, was down to
    2 tablets per week and no constipation. It was a miracle, I am now
    back to suffering and total misery, nothing is working. I pray every
    night that this will come back on a market that I can purchase this
    drug…I have heart problems for years zelnorm did not effect my
    heart. It was what my colon needed to be normal…Is it a govern-
    ment, possibly a market situation and pulled because it was not
    going to make them enough money especially with the law suits…
    I just find it all hard to understand,,,there are drugs fda approved
    that are so dangerous but are still being sold….whats the answer?

    Posted on August 13, 2009 at 11:38 pm

  • Joelle says:

    I to could only wish that Zelnorm would come back on the market..I go for weeks without going to the bathroom, the pain bloating nausea is just unbearable… All other remedies “DO NOT WORK” they make me sick…My PCP had told me that my GI dr would be able to orphan Zelnorm, since this is the only drug for me, but the GI dr said he could not…Any suggestions?

    Posted on September 6, 2009 at 12:21 am

  • Barbara says:

    I have suffered with IBS with constipation for 20 years. My Dr prescriped it for me 6 years ago. It was the only thing that ever helped me. I’m in pain all the time now. I WISH they would put it back on the market!!!

    Posted on September 21, 2009 at 6:56 pm

  • CMay says:

    Zelnorm was the only medication that worked for me! I was shocked when it was taken off the market. Now I suffer the misery of IBS that controls my life. I have a doctor’s note to be allowed to go to the bathroom whenever I need to because my IBS is so unpredicable. Once the weekly routine begins I could be in the bathroom for hours… I need to know where each bathroom is no matter where I am just in case. This is a horrible way to live. My digestive system controls my life and thus dictates who I am.
    When I was lucky enough to be on Zelnorm my life was different. I did not even think about the bathroom. I forgot that I had IBS. I felt normal. It is sad to think those days are over. I wish it would be put back on the market.

    Posted on October 9, 2009 at 10:53 am

  • Rose says:

    Dear ladies,
    One commentator hit the nail on the head–its a FEMALE script so, who the heck cares. We’re just women.
    I was SAVED by zelnorm, seriously. I was eating only raw veg, orn ot eating at all, drkining broth and trying to stay energetic enough to function. Then zelnorm was pulled. Well: I found a web forum suggesting Acetyl L Carnitine and I now take that 2 times a day, and it has helped. Plus megadoses of Vit C, and also I have improved my liver function with milk thistle, and also look for Liver Defense (whole foods). Here in the UK we also have Spasmonal, but I need all the parts: C, acetyl L carnitine and spasmonol. Works great. I live in terror of returning to the US where we dont have Spasmonol. Hang in there.

    Posted on August 15, 2010 at 12:03 pm

  • David N says:

    I’m a 45 yr old male who has used Zelnorm for 5 years. The article above cannot be accurate as the drug has been the ONLY THING that has kept me alive, as far as I’m concerned. The side affects of zero motility are completely debilitating and have put me in the hospital.

    I plan to appeal to the FDA. I don’t know what else to do. ‘Natural’ laxatives don’t do zip for me. Neither does Amitiza. And Austin Kirk can go shove it. Until I have a heart attack, if that’s even possible for me, then I have a better quality of life, like I can keep a job, than I would otherwise. This should be my choice, not his, not the FDA, noone else’s but mine. If I can volunteer to get shot in the head in Afghanistan, I can most certainly take this drug.

    Posted on September 30, 2011 at 4:08 pm

  • tewkewl says:

    I too am a Zelnorm success story. Since its recall, I have been to get the drug abroad. The drug enabled me to reach the top of my profession and eventually leave to start my own successful company. Now my foreign supplier has discontinued the drug. I don’t know what I’m going to do since nothing worked for me but zelnorm.

    Posted on November 2, 2011 at 3:37 pm

  • cathy says:

    I use magnesium oxide, take psyllium husk and still not having good results,,,I took Zelnorm and it did wonders for me .So why take it off the market just because one person had a heart attack? I’m 57 yrs. old and I eat the right foods byt, my gastro hasn’t come up with anything for me..I can take laxatives and it will work but, will this do damage to my colon?

    Posted on February 15, 2012 at 8:17 am

  • Rachelle says:

    I want Zelnorm back on the market. I suffer violent IBS attacks leaving me curled up on the floor in pain for hours. I then am unable to stand as my stomach has swollen twice its size and it feels like my skin will split in two while dealing with the passing of horrible belches and gas. Throwing up and migraine will follow and this can last a few days. I have tried various drugs and nothing helped until Zelnorm. Within a few hours of taking Zelnorm all my symptoms have settled and gone away. It is a miracle drug for me. I only take it when I have an IBS attack and it is super effective. There are thousands of drugs on the market with serious side effects, I can’t believe that Zelnorm is still not back on the market when nothing else similar has been created to help the few for which nothing else works.

    Posted on February 29, 2012 at 3:07 am

  • Betty says:

    Yes, I agree with everyone here Bring Zelnorm back! it is a miracle drug and was the only drug that finally worked for me then it is off the market; I too have attacks just as Rachelle described and nothing works like Zelnorm did, changing my diet; eliminating foods doesn’t work I have a healthy diet with lots of fiber based foods and water. Attacks still occur and I need to rely on laxatives which are not healthy for your system and they do not work like Zelnorm did; fast and effect relieve. The “Alternatives” available to do not work either! There are side effects with ALL medications prescription or over the counter; everyone needs to educate themselves and discuss with their Dr. any side effect concerns and use common sense. The only side effect I had was RELIEVE!

    Posted on March 4, 2012 at 12:35 pm

Add Your Comments

  • Have Your Comments Reviewed by a Lawyer

    Provide contact information below and additional private comments if you want an attorney to contact you to review a potential case.

    The information below will not be published to this page.

  • NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

  • This field is for validation purposes and should be left unchanged.