Irritable Bowel Syndrome Drug Linzess, What You Should Know

Irritable Bowel Syndrome Drug Linzess
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It’s been more than six years since there has been a drug approved for treatment of irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Now with the Food and Drug Administration’s (FDA) approval of Linzess (linoclotide), that has changed, but what should you know about this medication?

Do you have irritable bowel syndrome with constipation?

If you answered “yes” to this question, you are among the estimated 13 million people in the United States with this chronic condition that can have a serious impact on your daily life. Individuals who have irritable bowel syndrome with constipation typically experience constipation, hard or lumpy stools more than one-quarter of the time, loose stools less than one-quarter of the time, and abdominal pain.

Nearly three times as many people in the United States experience chronic idiopathic constipation, which is defined as having fewer than three bowel movements per week for three months or longer. Individuals typically need to strain at least one-quarter of the time and also can experience abdominal discomfort and bloating. As the name implies, the cause is unknown, not due to any overt disease or injury.

While occasional constipation can often be treated effectively with a mild over-the-counter laxative, people who suffer with IBS-C or CIC often find they must turn to laxatives more regularly or get a prescription, although not much is available (see below). Linzess differs from the other FDA-approved medication for these conditions because it is a guanylate cyclase-C agonist.

How Linzess works
Based on the results of clinical trials, experts believe Linzess works by attaching to the guanylate cyclase-C receptors in the intestinal tract, which then triggers an increase in the secretion of fluid. This action improves the movement of stool and also helps reduce abdominal pain.

More than 2,800 adults participated in the Phase III trials of Linzess, and the overall results showed that:

  • Abdominal pain relief was experienced by patients during the first week of treatment and sustained throughout the 12-week treatment cycle, although the maximum benefit occurred at weeks 6 through 9
  • The best relief from constipation occurred during the second week of treatment
  • Patients who switched to a placebo during the trials said their pretreatment symptoms returned within seven days
  • The recommended doses are 290 micrograms for people with IBS-C and 145 micrograms for people with CIC

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Some other things you should know about Linzess:

  • Dosing is once daily and should be taken at least 30 minutes before the first meal of the day
  • Linzess should not be taken by anyone younger than 18 years old. Although no studies have been done in children, animal studies showed that an adult dose of linoclotide caused the deaths of young mice.
  • The most common side effect of Linzess is diarrhea. Other reactions may include gas, abdominal bloating, and abdominal pain. Linzess should not be used by anyone who has intestinal blockage.

Other treatments for IBS-C and CIC
Lifestyle modifications are recommended for people who suffer with IBS-C or CIC. A gradual increase in the amount of fiber in the diet, mainly through fresh fruits and vegetables, legumes, and whole grains, is suggested, along with adequate fluids. Regular physical exercise, bowel habit training, and stress management also can be helpful in alleviating symptoms, but not everyone responds adequately to these steps.

Less often, treatments such as biofeedback, behavior therapy, and electrical stimulation have been used with varying success. For some patients, these measures can be an effective complement to other treatments.

The other FDA-approved medication for IBS-C and CIC is lubiprostone (Amitiza), an oral drug typically taken twice daily. Amitiza is known as a selective chloride channel activator. This means it increases secretion of chloride, which in turn increases fluid in the gut and helps move stool through the intestinal tract. Common side effects include nausea, diarrhea, gas, vomiting, dry mouth, runny nose, cough, fever, and headache.

Tegaserod (Zelnorm) was approved by the FDA for treatment of IBS in women. However, in 2007 the FDA asked Novartis (maker of Zelnorm) to suspend sales and marketing of the drug because it demonstrated a higher risk of stroke, heart attack, and unstable angina compared with placebo.

Individuals who suffer with these constipation disorders should consult their healthcare professional about all possible treatments for their condition. The introduction of Linzess to the marketplace for treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation offers patients one more option.

SOURCES:
Food and Drug Administration
Forest Laboratories Inc. and Ironwood Pharmaceuticals Inc.
Johanson JF. Review of the treatment options for chronic constipation. MedGenMed 2007; 9(2): 25

Image: Morguefile

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Comments

Diet plays a major role in IBS. Some doctors believe that food allergies cause some cases of IBS, although studies have been mixed. It is probably caused by a disturbance in the muscle movement (peristalsis) of the gut. This occurs in an allergic response where the brain triggers an immune reaction to a food. In that scenario the digestive tract is not activated. The vagus nerve is responsible for keeping the digestive tract in working order, contracting the muscles of the stomach and intestines to help process food, and sending back information about what is being digested and what the body is getting out of it. The function of the vagus nerve is to relay signals between the brain and various body systems to regulate heart rate, speech, sweating, blood pressure, DIGESTION, glucose production, and certain aspects of breathing. Not only is the nerve responsible for innervating organs, but it also controls certain skeletal muscles, such as the larynx, but only if the brain recognizes what ever you have in your mouth as food, or a substance beneficial to the system. Avoidance of allergenic substances is of utmost importance for optimal gut health, which is a precursor to general health. Foods such as red meat, dairy products (milk, cheese, and sour cream), chocolate, alcohol, and carbonated beverages (sodas) may trigger or aggravate the symptoms in some people. Gluten can also be a problem for some people with IBS.
My Insurance doesn't want to pay on the Linzess. I had a coupon that I used at first. It really works. I had nausea a lot anyway, so I am afraid to take the Amitiza. I might have to give it a try because the other is so expensive.
My insurance made me try the other drug Amitiza and it did not work at all....after trying it for one month and having my doctor send the insurance company information saying I tried it...they ended up paying for the Linzess. Maybe they will cover it after you try the other one if it doesn't work! Wish you the best
Melanie: Thank you for sharing your experience with Linzess. It demonstrates that patients need to try every option, work with their doctor and be persistent in seeking good care! Unfortunately, the current system doesn't always make it easy to do, but you succeeded.
Deborah Mitchell: After about a week on Linzess it seemed to stop working. I was so sad so I went back to my doctor and she said I should take 500 mg of magnesium. So far it has been wonderful and working almost daily! Just wanted to share the information with you and maybe you would find it works for you as well! Good luck
Melanie: Thank you for sharing the information about magnesium. Perhaps it will help others as well. Wishing you continued success!
I'd like to know what kind of magnesium Deborah takes and how much? Carol carter
My Insurance wanted me to try Amitiza also. I know the Linzess does work, so i didn't want to change. Maybe I will try what you did. If it doesnt work, then? Thanks for the idea.
Linzess really has helped my digestive issues, which despite other comments, I believe there may be a genetic link. My mother had issues all her adult life, constipation, hemmoroids, IBS, diverticulitis. Her doctors prescribed diets, fiber, do this, don't do that, and the next month, reversing the do's and don't's. It took her life when her gut ruptured. My symptoms began slowly in my late 20s, progressing to diverticulosis/diverticulitis. First prescription for new drug was Amitiza. Nausea set in in minutes. Then diahrrea ... 18 watery trips to toilet,.Linzess and Metamucil have solved my issues.. HOWEVER even 145mg is too strong. I buy extra empty caps, open the Linzess cap and carefully divide the contents in 2 doses, putting one dose in the empty cap.
Sorry to hear that your insurance won't pay for Linzess. I am not a physician so I can't make any medical recommendations. However, you may want to talk to knowledgeable professionals about making dietary changes, including the possibility that gluten may be an irritant, and also look at some stress management options. Lifestyle changes can be very effective. Good luck to you.
Talking about stress. My 94 year old mom gets ill, I have nights that I don't sleep. Doing with out sleep is the main reason my irritablebowl will really get bad. Even though I don't feel tired, in a day or two I will get so sick..
Linzess completely got my IBS symptoms under control, I liked Zelnorm better however gotten used to Linzess, you have to keep taking it for a long time, it takes few month just to start working, at first it was terrible diarrhea, then it finally stopped and now I don't even have much constipation if I forget to take my morning pill. You also have to avoid eating dairy and fatty foods, try to avoid wheat. I tend to eat healthy, take probiotic, aloe juice from Univera supplements and plenty of yogurts. Don't lose hope, keep taking it, Linzess got me my life back.
I took this, only one pill, and the lower dose pill! I had a severe allergic reaction to it. Almost died! I have never had an allergic reaction to anythimg, and I take no other medications! Make sure you know all the facts!!!!!!!!!!!!!!!!!!
Just wondering if this drug is Gluten and dairy free? I really want to get started on it but can't until I find out. Thank you for your help, Candace
Candace. Thank you for your question. I suggest you contact the pharmaceutical company (Ironwood Pharmaceuticals) and ask them. Good luck.
I been taking linzess for a week and have not went to the bathroom yet . how long should I wait . please help.
I have taken Linzess for 2 weeks now. First week wonderful, BM every day, this week nothing. I am so miserable.
I've been on Linzess now for 14-15 months and it has worked wonderful, until now .....my stomach pain is back with avengence and Ive been having two BM a week.....so my doctor told me to stop the linzess and put me on Amitiza caps 24mcg/two tabs daily....my question is how does the Amitiza work as far as a BM goes, I know with linzess I pretty much Stayed within two feet of a bathroom for the first few weeks after that it was great....but I think I plateaued. ....if thats possible. Does everyone get them severe stomach aches where you can barely move without holding your stomach, oh they are the worst....can any one offer some in sight on Amitiza, and best time to take it, how long before relief kicks in ect....
two BM a week.....so my doctor told me to stop the linzess and put me on Amitiza caps 24mcg/two tabs daily....my question is how does the Amitiza work as far as a BM goes, I know with linzess I pretty much Stayed within two feet of a bathroom for the first few weeks after that it was great....but I think I plateaued. ....if thats possible. Does everyone get them severe stomach aches where you can barely move without holding your stomach, oh they are the worst....can any one offer some in sight on Amitiza, and best time to take it, how long before relief kicks in ect.... Thanks for listening....I also am gluten free, no carbonated drinks ect...I still have to take mirolax fiber daily....it makes me soo nauseated. ...and serves no relief....arrgh.
I started taking Linzess 145 for CIC. At first I had a bit of diarrhea but then it worked really well. A few weeks later it stopped working. Dr then prescribed the 290's and they work well but after taking my pill in the morning I feel really funny, like chills, tingling in my limbs, lightheaded, weak for a couple of hours. I'm wondering if my vagus nerve is irritated by the Linzess. I'm a little afraid of continuing to take it, I've searched on the net and I don't see these symptoms as typical side effects of Linzess.
I am having a lot of these same issues, tingling, lightheaded and weak. Wondering what you found out?