Linzess is NOT for diarrhea-predominant Irritable Bowel Syndrome.
Linzess is NOT be used in patients 17 years of age and younger. It may harm them.
Linzess is NOT to be used in patients with known or suspected mechanical gastrointestinal obstruction.
As Linzess received US FDA approval in August 2012, the medication has not been on the market long enough to determine safety or effectiveness for long term use for IBS-Constipation.
Clinical studies to determine the impact of age and gender on the actions of Linzess have not been conducted.
As of November 2012, Linzess, to be known in Europe by the brand name Constella, still awaits approval by the European Commission.
Linzess - How well does it work?
In the clinical trials for this medication, IBS patients fared better -- 7 percent to 25 percent better -- when taking Linzess than when taking dummy pills (placebos).
What is Linzess?
Linzess (the generic name is linaclotide) is a drug manufactured by Forest Laboratories and Ironwood Pharmaceuticals, and available by prescription only in the US. Linzess is a guanylate cyclase-C agonist. Linzess and its active metabolite bind to GCC and act locally on the luminal surface of the intestinal epithelium.
Activation of GC-C results in an
increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). Elevation in intracellular cGMP stimulates secretion of chloride and bicarbonate into the
intestinal lumen, mainly through activation of the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, resulting in increased intestinal fluid and accelerated transit.
In plain English, Linzess changes stool consistency and increases stool frequency.
The recommended dose of Linzess is 290 mcg taken orally once daily on an empty stomach, at least 30 minutes prior to the first meal of the day. Linzess is not meant to be taken only as needed; it is a daily maintenance drug. Linzess is meant to increase the movement of stools through the bowels, which relieves the IBS symptom of constipation, but Linzess does not cure IBS (nothing does). For those who are helped by Linzess, the drug can reduce abdominal pain and constipation.
Once you stop taking Linzess your IBS constipation and other symptoms will likely return very shortly. For safe lifelong management and prevention of constipation and bloating due to Irritable Bowel Syndrome, the IBS diet and a soluble fiber supplement such as organic Tummy Fiber Acacia are healthy alternatives. Fennel is a safe herbal tea that can be extremely beneficial for bloating associated with IBS.
Who should NOT take Linzess?
Linzess is not recommended for use by pregnant or breast-feeding women, and it is absolutely not to be used by children. Linzess should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether linaclotide is excreted in human milk; caution should be exercised if Linzess is administered to nursing women. Linzess is not to be used by people with diarrhea. Linzess should also not be used by anyone with a known or suspected bowel obstruction (intestinal blockage).
Linzess clinical trials
The FDA based its decision to approve Linzess on the results of two randomized, double-blind, placebo-controlled clinical studies. 90% of the patients in the trials were female. In the open-label, long-term trials, 2147 patients with IBS-C received 290 mcg of Linzess daily for up to 18 months.
In these trials, 29% of patients had their dose reduced or suspended secondary to adverse reactions, the majority of which were diarrhea or other GI adverse reactions.
Linzess side effects
During clinical trials, the following list of adverse events occurred more often in patients on Linzess than in patients on the placebo:
Infections and Infestations: viral gastroenteritis
Nervous System Disorders: headache; fatigue
If you experience any side effects while taking Linzess, call your doctor. If you experience new or worsening abdominal pain not typical of your IBS, or severe diarrhea, call your doctor.
In the US, estimates are that Linzess tablets will sell for somewhere in the range of $6 - $7 each. The drug is expected to generate $2 billion in annual sales for Forest.
Linzess patient counseling
Linzess patients should be instructed as follows:
Do not give Linzess to children under 6 years of age.
Do not give Linzess to children 6 to 17 years of age. It may harm them.
Keep Linzess in the original container. Do not subdivide or repackage. Protect from moisture. Do not remove desiccant from the container. Keep bottles closed tightly in a dry place.
Take Linzess once daily on an empty stomach as prescribed.
Swallow the capsule whole and do not break apart or chew.
Stop Linzess and contact your physician if you experience severe diarrhea.
Seek immediate medical attention if you develop unusual or severe abdominal pain, and/or severe diarrhea, especially if in combination with hematochezia (bloody stools) or melena (black, tarry stools).
Alternatives to Linzess
For safe and effective non-drug approaches to managing IBS symptoms, learn how the organic Tummy Fiber Acacia can help relieve constipation without risks or side effects, why fennel can be extremely beneficial for bloating, how peppermint can relieve and prevent abdominal pain, and how gut-directed hypnotherapy addresses the underlying pathology of bowel dysfunctions and relieves all IBS symptoms.
If you feel confident that your constipation and bloating are symptoms of Irritable Bowel Syndrome, information is key. Learn all you need to know about this disorder with The First Year: IBS, an essential guide to successfully managing Irritable Bowel Syndrome.