The side effects of Linzess

Linaclotide (brand name Linzess) is a medication prescribed to adults to relieve symptoms of irritable bowel syndrome (IBS), IBS with constipation and chronic idiopathic (unknown) constipation (CIC). Linzess is a guanylate cyclase-C agonist that works to treat IBS, IBS-C and CIC by increasing production of water and chloride in the intestines, promoting movement of waste and food through the gastrointestinal system and by suppressing pain signals in the small and large intestines.

While Linzess may help manage symptoms of IBS, it will not cure the chronic diarrhea, constipation and pain associated with irritable bowel syndrome. Once you stop taking Linzess, your IBS symptoms will return in seven to 10 days.

According to the U.S. Food and Drug Administration, Linaclotide "has caused death in laboratory mice" [1]. The FDA also warns that children between six and 17 years old should never take Linzess due to lack of research information regarding the effects of Linaclotide on children and adolescents.

Linzess may cause multiple side effects [2] that include:

• Abdominal pain and cramping;
• Abdominal distension;
• Moderate to severe diarrhea beginning within a few days of taking Linzess;
• Black, tarry stools or stools containing blood (requires emergency treatment);
• Nausea and vomiting;
• Dehydration and weakness due to chronic diarrhea;
• Rapid heartbeat;
• Dizziness, fainting;
• Inability to control bowels;
• Body/joint aches;
• Sneezing, sore throat, congestion;

Linzess may cause other side effects not listed, such as symptoms of an allergic reaction [3] to Linaclotide. Hives, severe itching, difficulty breathing, chest tightness and swelling of the throat and tongue indicate an impending allergic reaction that needs immediate medical treatment.

Clinical trial results with Linzess

Nine percent of IBS-C patients participating in placebo-controlled clinical trials discontinued their involvement in these trials prematurely when Linzess caused adverse reactions, specifically abdominal pain and diarrhea. In long-term trials, 29 percent of 2147 patients with irritable bowel syndrome (with constipation) had to reduce their dosage of Linzess due to adverse reactions.

In trial patients suffering chronic idiopathic constipation, 16 percent reported diarrhea and two percent reported severe diarrhea. One percent of CIC patients taking Linzess reported fecal incontinence. In addition, eight percent of trial subjects [4], diagnosed with CIC discontinued participation prematurely due to suffering severe adverse effects.

Facts about Linzess:

• Since Linzess recently received approval by the FDA in 2013, no longitudinal studies have been performed to determine whether Linzess may be carcinogenic.
• So far, no long-term adverse effects have been reported by doctors or their patients.
• Linzess may interfere with the ability of the intestines to adequately absorb nutrients due to its stool-loosening properties.
• Although Linzess does not directly cause arrhythmia or kidney failure, people taking Linzess may suffer these conditions due to severe diarrhea dehydrating the body.
• Linzess may worsen hemorrhoids. Constipation, diarrhea and straining while defecating are known to exacerbate symptoms of hemorrhoids [5].
• It is not known whether Linzess worsens diverticulitis or appendicitis. More research is needed to determine its affect on these conditions.
• Pregnant women and children should NOT take Linzess. No research has been done to establish its efficacy or safety children under 17 or pregnant women.
• Since Linzess induces diarrhea, it could promote fecal impaction if someone takes this medication for an extended period and then suddenly stops taking it.
• Laxatives impair the ability of intestinal muscles [6] to push stools out of the body. Long-term use of Linzess may result in muscles "forgetting" how to move stools through the intestines.
• A motility disorder associated with nerve damage, overuse of laxatives and dehydration, colonic inertia will not respond favorably to Linzess since Linzess promotes loose stools and diarrhea.
• Linzess is not addicting psychologically. However, long-term use of Linzess may make the intestines dependent on the medication for moving wastes out of the body.
• Using Linaclotide is contraindicated in people [7] diagnosed with a mechanical gastrointestinal obstruction. Since Linaclotide causes diarrhea and/or accelerated movement of waste, it can worsen the blockage.
• The possibility exists that Linzess could promote anorectal nerve damage [8] since one of the primary causes of fecal incontinence/anorectal nerve damage is chronic diarrhea or constipation.
• Average cost of monthly prescription [9] for Linzess is around $350 for 30 pills.

Drug interactions with Linzess

Linaclotide is known to interact moderately [10] with 25 different drugs. Some of these medications include desogestrel/ethinyl estradiol, levonorgestrel and thyroid desiccated. By causing rapid and sometimes severe onset of diarrhea, Linzess inhibits absorption of these and many other oral medications, which significantly reduces the medication's ability to exert beneficial health effects.

Linzess interaction with food

If you take Linzess with food, you may suffer increased side effects involving abdominal pain, diarrhea and gas. To reduce symptoms of gastrointestinal intolerance, Linzess needs to be taken 30 minutes before you eat your first meal of the day.

How does Linzess affect colonic microbiota?

Composed of hundreds of different genes and over 1000 bacteria types, colonic microbiota [11] (gut/intestinal flora) wields such influence on our health that it's often referred to as a hidden "organ".  Changes to the gut microbiome can benefit or harm someone's health, depending on whether certain bacterial species overwhelm another bacterial species. Disruption of colonic microbiota is called dysbiosis, a condition that may promote obesity, IBD, diabetes, ulcerative colitis and malnutrition.

Linzess can have a negative impact on bacterial populations in the gut by dramatically altering intestinal chemistry. When the drug binds to intestinal epithelial (surface) cells [12], it elevates levels of cyclic guanosine monophosphate, a substance that increases secretion of bicarbonate, water and chloride in the intestines. Bicarbonate and chloride radically upset the pH level in the intestines, making the gut a more attractive place in which "bad" bacteria responsible numerous diseases thrive.

Linzess reviews

Linzess users providing reviews on WebMD [14] state the following about Linzess:

• "Felt sick within 30 minutes of taking one dose--weak, light-headed, severe diarrhea".
• "Had severe anxiety, depression and abdominal pain. Felt 100 percent worse!".
• "Caused bloating, abdominal pain and gas".
• "Linzess caused a bad burning sensation in my throat and esophagus. Made it difficult for me to swallow".
• "Inconvenienced me with unexpected episodes of severe diarrhea".
• "I had gas pain so severe I couldn't sleep through the night".

Makers of Linzess

Allergan and Ironwood Pharmaceuticals, Inc. manufacture and market Linzess. Allergan [15] is known for producing Botox, Juvederm and some psychiatric medications while Ironwood [16]  is behind Linzess and a medication for gout relief.  This is the first time either company has manufactured and marketed a drug for relieving symptoms of IBS, IBS-C or CIC.

References