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Linzess (linaclotide) is a new prescription drug which can be used to treat both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults. It is the first treatment available in a new class of medications called GC-C agonists. It received FDA approval in the USA on 30 August 30 2012 and became available in pharmacies in December 2012. It is designed to relieve abdominal pain and constipation associated with IBS-C and constipation and hard stools associated with CIC.

How effective is Linzess in clinical trials?

A Phase I randomized, double-blind, placebo-controlled study described in January 2009 in the American Journal of Gastroenterology found that 42 patients with chronic constipation experienced relief with few side effects.

Conclusion: Linaclotide improved bowel habits and symptoms of patients with chronic constipation. Further randomized controlled trials are warranted. Pubmed article: Johnston JM, Kurtz CB, Drossman DA, Lembo AJ, Jeglinski BI, MacDougall JE, Antonelli SM, Currie MG.

A second study published in the American Journal of Gastroenterology looked at 804 patients over a period of 26 weeks. Statistically significant improvements in symptoms including abdominal pain, abdominal bloating and number of bowel movements were seen in patients taking linaclotide versus those given a placebo.

Conclusion: Linaclotide at a dosage of 290ug once per day significantly improved abdominal and bowel symptoms associated with IBS-C over 26 weeks of treatment. Pubmed article: Chey WD, Lembo AJ, Lavins BJ, Shiff SJ, Kurtz CB, Currie MG, MacDougall JE, Jia XD, Shao JZ, Fitch DA, Baird MJ, Schneier HA, Johnston JM.

REVIEWS OF LINZESS

Review by Kathleen

I have been taking Linzess for nine months. As far as I am concerned it is a miracle medication. I have been dealing with IBS-C for 18 years. I used to take Zelnorm when I was in college until it was discontinued, but that only treated the horrible belly pain.

To regulate my bowels I would take daily probiotics, intermittent laxatives, daily fiber supplements, a morning spinach/fruit smoothie, one meal with beans and I would still only have two or three bowel movements a week. Since day one of starting Linzess I have daily bowel movements and I have stopped taking the extra supplements and can eat well-balanced meals instead of overdoing the fiber. It has changed my life.

Review by Kelly

I've had IBS for about 15 years. Miralax quit working and I was drinking magnesium citrate about once a week to clean myself out. My doctor then put me on Linzess. The first couple days were awful, I couldn't take a drink of water without having to run to the bathroom.

After about two weeks things started getting better with a normal bowel movement every day. One month later I am so bloated my pants don't fit, I'm not even hungry my gut is so massive and I'm having constipation problems again.

Review by Terry

I’m 37 and I was diagnosed with IBS-C about a year ago. However, I’ve struggled with constipation since my early twenties. By the time I sought out a GI specialist I was in desperate need of intervention. The bouts of constipation had become so taxing on my life that I had a hard time keeping up with normal functions like work and a social life.

I found myself calling out of work and missing social functions more and more because I couldn’t get past the constant bloating, nausea, cramping and fatigue. I would sit on the toilet for hours trying to move my bowels.

After meeting with the GI specialist and trying Miralax and fiber substitutes such as Metamucil with little to no relief, he finally suggested that I try Linzess. As others have mentioned I was excited to finally have something that would provide relief but the joy was short-lived.

Initially I was prescribed 145mcg which is the lower dose. During the first couple of weeks I suffered from extreme diarrhea but I knew going in that this was a typical side effect. You’re supposed to take it before breakfast every morning but that didn’t work with my work schedule so I would take it an hour or so before bed. That was a pain because I would find myself running to the bathroom all night and would be exhausted in the morning.

However, after a couple weeks the bouts of diarrhea subsided and I thought things were mellowing out. I was wrong! After some time I noticed that sometimes I would have a bowel movement and sometime I wouldn’t, until it stopped being effective at all and I would be left with the worst bloating and cramping on top of being constipated.

I made a follow-up appointment with the GI specialist to tell him how things were going and at that time he decided to increase the dosage to 290mcg. I found myself in the same situation, where I had extreme diarrhea and then a lull before it stopped working altogether.

After making another follow-up appointment with the GI specialist he decided to prescribe Amitiza which after reading the reviews I’m afraid to even take. It sounds like the side effects are just as bad.

Review by Laura

I have had digestive issues since I was a kid but I wasn’t diagnosed with IBS-C until about two years ago. I haven’t tried certain diets or a lot of different meds. I know Metamucil doesn’t work for me or laxatives. I’ve only had luck with magnesium citrate to get relief.

My GI prescribed Linzess and I was so excited that maybe I would start feeling better. I’ve been using Linzess for about six months now. At first all it did was cause me to have diarrhea right after I ate and a little every time I would eat after that. It didn’t help my anxiety because I still had to make sure there was a bathroom around.

So just now I’m starting to wonder if I should stop taking this medication since it will cause diarrhea for about two to three hours straight but then leave me bloated and constipated for three days or so. So it’s not keeping me regular, just helping me empty every so often. I’m thinking I need to try something else because the bloating is uncomfortable and even though I’m working out regularly I’m not seeing any weight loss.

Review by Taylor

So I am a 23 year-old female and right around when I graduated college I started to notice something different in my digestive pattern. Truth is, my constipation started around sophomore year in college, but I began to pay attention to it at the end of my senior year because I was attributing the constipation to the never-ending stress that my education was giving me.

I decided to meet with a GI specialist and he prescribed Linzess. I was so excited that I could return to the state of 'normal' with only one pill a day! I began the treatment and everything was marvelous. I was going to the bathroom once a day and I wasn't straining like I had been before.

It was right around the second week of treatment that I started to notice diarrhea and I knew this was a side effect of the medication, so I stuck through it. A little bit of diarrhea never hurt anybody right? Wrong.

On the ninth day of taking Linzess I developed this insufferable (and yes I use the word 'insufferable' with strong emphasis) pain that accompanied every bout of diarrhea. To give you a small picture, I was bent over for six to seven hours screaming in pain and having three or four rounds of green diarrhea.

I made it through and went to bed that night thanking God that he had given me the strength to get through the day because in truth, I have never experienced something so painful before. So there I was the next day, waking up and ready to go about my business when around 4pm I was hit with the same insufferable pain and diarrhea and screaming for someone to take the pain away.

My Dad ended up driving me to the hospital and I was given a dose of morphine, Demerol and Dilaudid all at the same time because of the amount of pain I was in. I think the nurse told me it was equivalent to around 11mg of morphine, which is quite an intense amount of opioids in the human body. Needless to say I was very drugged and vomiting from the nausea the pain medication had caused, but I was so very grateful that the pain had gone.

I was discharged around 1am and went home and slept until around 3pm the next day. When I awoke, I ate a small amount of food and then to my immense displeasure I started to feel the pang of the same pain again. As I ran to the bathroom to have more diarrhea, I was crying, saying I wouldn’t make it through this time.

There I was again rushing to the hospital, running red lights and praying to God to end the pain. I was again admitted to the ED and given pain medication and I stayed in a drugged-up state so grateful for the relief while the doctors were scratching their heads wondering what was going on with me. I had every test done to me and they all came back normal...so they sent me home again saying it was a side effect of Linzess.

It felt like I was in a blurry haze the next day. I was so drugged and tired, I didn’t feel like moving, eating or doing anything. It was around 6pm when once again I felt the pain. This was the third night in a row where I thought I was dying. I'm honestly surprised the neighbors didn’t call the police from the screams.

The diarrhea came and unsurprisingly I was being whisked off to the ED, where I now knew the staff by name and they all knew the routine of my admittance. I was given a cocktail of pain meds again and the doctors said they were going to admit me for further observation. Finally, I could feel a little bit of relief that I had support 24/7 now if I were to have a pain spell again.

The next day in the hospital all of the doctors rounded on me, basically saying they didn’t know what was wrong and that I had a really bad reaction. I was put on a liquid diet and mind you, I had already not being eating because of the pain. I was nothing short of absolutely miserable. I was starving, hopeless and afraid of doing anything.

I ended up being discharged the next day because my pain had somewhat stopped and I just wanted my own bed. Overall I ended up losing seven pounds and my mental health has suffered immensely from this drug. I am afraid to eat or drink and with any slight discomfort in my lower digestive tract I can start to feel my heart race. I no doubt have some type of acute stress disorder because I can only bring myself to talk about this ordeal four months after this incident.

And even as my heart rate is pulsating as I’m writing this, I am hoping that someone can benefit from my experience. If you or someone you know is about to start Linzess, please think about it carefully. Have your doctor tell you every risk and every benefit. Yes, this drug has worked miracles for some people, but also this drug has ruined my life in a way.

I’ve seen psychologists and doctors after this incident to try to 'fix' my mental health, but only time is helping me I suppose. I’m not trying to gain sympathy with this post, but rather offer a warning about the drug Linzess. Thanks for sticking with me through my story.

Review by Carey

I am a 60-year old male. I've suffered with constipation all my life. I recently became so addicted to senna laxatives I was taking 22 Senokot, two cascaras plus eight stool softeners a night! When it finally sent me to the hospital (I was in there five days) I was in very bad shape.

After a series of tests including colonoscopy, endoscopy and CT scans they found nothing organic, just extremely slow gut transit and lack of peristalsis. I tried the Linzess my doctor gave me. The first time it was like a miracle (145mcg) but it stopped working within two weeks.

I started on the 290mcg and it worked today. Not to perfection, but better than an impaction which I fear. At first Linzess made me extremely bloated but that seems to be less now.

Just to give you an idea how bad I am, I take four sennas, two cape aloes, four stool softeners, probiotics, a supplement by Pure Encapsulations called Motil Pro and the 290mcg Linzess and I don't have the runs. I go at number six on the Bristol stool scale (mush).

I know that I do have a redundant sigmoid which is most likely the root of my condition. I also was tested for dyssynergic defecation disorder and pelvic floor disorder. To make things even more complicated I have lost 45lbs in the last year or so. I was told by one specialist that I may have damaged the mucous lining of my colon, which is where nutrient absorbtion occurs.

Lastly I have found a medication available in Canada named Resolor (prucalopride). It is not approved by the FDA but it's available by mail order pharmacy and it is, as of now, the only prokinetic agent specifically for the colon! If my doctor will allow me, you know I will give it a shot.

I hope that everyone who is going through this hell gets the help we need. This has changed my life drastically. And when I see people take such a simple thing as being 'regular' for granted, not realizing that it's a major blessing, it blows my mind. Good luck to all and God bless us.

Review by Robyn

I have been taking Linzess for a year now. It's amazing. I had gastric bypass and severe constipation with impactions with a history of IBS-C. The first time I tried this medicine I hated it. It was like my rectum was an unpredictable volcano! So I stopped it. By my second ER visit for impactions, I tried it again and now I can't live without it.

Once you get on a schedule, it's easy. I take it first thing in the morning with water and coffee. I take my shower, get dressed, dry my hair and boom, it kicks in. Never fails. Within 40 to 60 minutes it clears me out. Maybe once again about 15 minutes later and I'm good for the entire day.

It does not last all day; it does not last more than two hours tops! It pushes through your system clearing out everything in front of it and it's done! Amazing. No pain, no cramps. If you tried this once, try it again. Once you get used to it, it's worth it. Trust me, if you have ever had an impaction, you want to try this.

Review by Karen

I am 67 years young. I have suffered for 50 years with IBS. Back when I was a teen it was called spastic colon. In my 30s the term IBS was born. I had IBS-D...a great way to stay skinny, as everything that went in came out.

About a year ago I developed IBS-C. For the first time in 50 years I couldn't have a BM. I suffered in horrendous pain. My GI gave me Linzess. Then I remembered the Dulcolax I had from my colonoscopy.

Now once a week I take two Dulcolax at bedtime and the next morning my Linzess. Within three to four hours I have several BMs. No pain, cramping or vomiting. If I don't do this regimen weekly I am in serious pain.

Review by Tonya

My doctor prescribed Linzess on Thursday. I have been on it for five days and there is still no 'movement'. I am 43, exercise daily, I'm not overweight, I eat healthily with extra fiber. It all started in my mid thirties when I went from daily bowel movements, to every other day, to hopefully once a week.

I told the doctor that the only way I go is with help from Metamucil, tea, Dulcolax, Activia yogurt and a Fiber One bar every day! If I do not do this the pain in my back and stomach is just unbearable. As for my review on Linzess - I still haven't gone to the bathroom. I feel nausea, bloating and I'm getting discouraged. All I wanna do is go! Do I give this a little longer? I'm seriously frustrated.

Review by Richard

I have had IBS-C for decades and was given Linzess by my MD. I took it as directed and it was a disaster. I would describe it as cholera in a bottle. The diarrhea started unannounced, was explosive and lasted 10 hours after ingestion. I called my doctor's office and the nurse said this was normal, would abate in time and wasn't an abnormal reaction. I persevered for a week before I quit. I can't imagine ever trying this drug again. The experience was awful.

Review by Sarah

I have been taking Linzess for over a year for IBS-C. It has been a never-ending game of guess work, even on an auto-immune IBS diet. I took the lower dosage of 145 for a while. It was too effective for a month with explosive, unpredictable bowel movements for hours in the morning. Then it become ineffective with time and regular use.

My gastroenterologist increased my dose to 290 and again it had too much effect. We decided it was too high a dose and I have been guessing each day whether to use the high or low dose depending on what I anticipated for a day. I can't travel while on the medication because you need constant access to a toilet.

I have noticed sensation changes in my fingers and my thyroid eye disease flares up about two hours after my dose is taken. Over time, I have been gaining weight. I started to look alcohol puffy and I am not joking as a colleague asked if I was all right.

This month I just gave up and quit. I have lost 10lbs of water weight in a week. My eyes are looking much improved. I literally look 10 years younger and healthier. The inflammatory reaction around my left eye has not occurred since I stopped taking Linzess.

I have been functioning with coffee enemas twice per day. It is more time-consuming in one way but the bowel movement is predictable and then I don't worry all day about where the bathroom is or whether it is gas I am going to pass or fecal matter. I just can't go back on it.

Review by CM

After reading several of the reviews of Linzess I can tell you that my experience on this new medication has been nothing short of amazing. I was diagnosed with IBS with constipation in November 2009 and following many excruciating trials of over-the-counter remedies I visited my gastroenterologist who prescribed Amitiza initially. Although I took a modified dose of the drug due to its rather harsh side effects it worked fairly effectively for the next four and a half years and then suddenly stopped working.

Thankfully Linzess was available and so I began taking it about six months ago, once per day approximately 30 minutes before breakfast (145mcg) and within 20 minutes following the morning meal it works like a charm. The only caveat is that I need to be close to a bathroom for up to 30 minutes as I continue to have episodes of diarrhea. The fact that I only have to take this medication once daily is a blessing...

Review by Julie

Four days ago my gynecologist gave me a boz of samples of Linzess to see if it might help my chronic constipation that I have had since I was a teenager (I'm now 60 years old). I'd been using Miralax for years but that didn't seem to be working as it's supposed to leaving me with hard stool constipation.

I've stopped using Linzess after the first four days because my lower abdomen was so bloated, causing sharp pains in the area of my colon and bowels. I had a colonoscopy just three months ago so I don't understand the reason I have such terrible constipation and bloating with the Linzess.

Review by Ron

I'm 65. I have suffered from IBS-C my entire adult life. In August I started experimenting with office samples of Linzess. I took it sporadically for a few months and then had the doctor prescribe it for me. At the same time I was taking the probiotic Align and I had just started on that as well.

It was when I got off the Align for about a week and tried dosing Linzess for 12 straight days that I had a savage attack of abdominal pain (trapped gas and splenic flexure syndrome). I had never taken Linzess for more than three or four days in a row prior to the 12-day stint. I got back on Align immediately, discontinued Linzess for a few days and in four or five days the trapped gas abated.

My conclusion is that Linzess is a very potent and effective laxative, perhaps to be taken every second or third day but not without the Align buffer. On its own, taken day after day, my experience suggests that Linzess may actually contribute to abdominal discomfort and bloating rather than alleviate it. I realize that this will vary from individual to individual, but I just wanted to share my own experience. Word of caution: you may experience thunderous diarrhea with Linzess, often after an initial somewhat firm stool. It's like milk of magnesia to the tenth power.

Review by Donna

I have suffered from IBS-C for 30+ years. I eat heathily and exercise regularly. I am not overweight. I could never understand why I have IBS-C. My gastroenterologist recommended Linzess and I took it as directed. Within 45 minutes I felt a warmth spread in my upper sternum, a definite pressure, a feeling of fullness, sweating and nausea. I also got a little short of breath but that may be due to the anxiety I was feeling because I thought I was having a cardiac event.

I called the gastroenterologist on call and he said he had been prescribing Linzess for about two months and none of his 17 patients reported experiencing any side effects. He instructed me to go to the ER if my symptoms did not resolve in the next hour just to rule out a cardiac event. I had had a complete physical with a cardiac work-up two months prior so that was ruled out. I began to feel better after 30 minutes when my discomfort peaked so I had a total of two hours of discomfort. I also take Prilosec so it was not GERD. I will never take this med again.

Review by Kristi

I have been on Linzess with amitriptyline for about a month and a half and I have noticed that I feel horrible from constipation, cramping and nausea if I don't take it at all. However if I take it as prescribed, before I eat first thing in the morning, I feel sick all day! It only took me two times of doing that before I figured out that it was the Linzess. So, as long as I take it at night before I go to bed, with the amitripyline, I am better.

I am so glad to have found your website and to read about the food side of IBS. My GI doc has said that there really is no definitive study to show that foods can trigger IBS. So I have thought that it is in my head that eating certain things - most things - actually makes me sicker. Thank you!

Review by Lynn

Yes, Zelnorm is off the market, but three months ago I was given this new drug that was approved by the FDA in the United States called Linzess. I was on Zelnorm for years (even after they took it off the market in the US) and it was a miracle pill. I have only 18 inches of colon left and I had suffered from horrible constipation. None of my doctors could figure out why I have constipation instead of diarrhea - they still can't figure it out and it is 12 years since my surgery.

Anyway, I had seen there was going to be a new drug out in place of Zelnorm. It was available three months ago and I have been on it since it became available. It works exactly like Zelnorm! You take it 30 to 60 minutes prior to eating. It is another miracle drug for me.

Do you suffer from IBS? Have you tried Linzess? Please contact Sophie to send in your review.

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