- Trulance vs Linzess: Main Differences and Similarities
- Trulance vs Linzess Side by Side Comparison
- Linzess (Linaclotide) For IBS With Constipation Or Chronic Idiopathic Constipation Now Available, USA
- About Linzess (linaclotide)
- Irritable Bowel Syndrome with Constipation
- Chronic Idiopathic Constipation
- Drug Injury Watch
- Here Are Some Of The “Findings” From An April 26, 2016 Document Which Seems To Have Disappeared Only Two Days Later
- Free Linzess Case Evaluation
Trulance vs Linzess: Main Differences and Similarities
Trulance and Linzess are two medications used to treat adults who have irritable bowel chronic idiopathic constipation (CIC). Both medications can also treat constipation from irritable bowel syndrome (IBS-C). Classified as guanylate cyclase-C agonists, these medications work by increasing bowel movements and decreasing pain.
Trulance is the brand name for plecanatide. Initially approved in 2017, it is a newer drug than Linzess. Trulance acts locally in the intestines and is not heavily absorbed.
Trulance is supplied as a 3 mg oral tablet. It can be taken once daily with or without food. As early as one week after starting treatment, improvements in bowel movements can be seen in those with CIC.
Trulance is not recommended in people less than 6 years of age to 18 years of age.
Linzess is also known by its generic name, linaclotide. It was FDA approved in 2012 and works very similarly to Trulance.
Linzess is available in 72 mcg, 145 mcg, and 290 mcg oral capsules. It can be taken once daily depending on the condition being treated. However, it must be taken on an empty stomach at least 30 minutes before breakfast.
Like Trulance, Linzess is not recommended in children younger than 18 years of age.
Trulance vs Linzess Side by Side Comparison
Trulance and Linzess are very similar drugs that belong in the same class. They have several differences and similarities which can be found below.
|Common Side Effects|
|Is there a generic?|
|Is it covered by insurance?|
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|SingleCare Discount Price|
|Can I use while planning pregnancy, pregnant, or breastfeeding?|
Trulance and Linzess are similar drugs that treat chronic idiopathic constipation (CIC) and constipation with irritable bowel syndrome (IBS-C). They are both guanylate cyclase-C agonists that work the same way to draw out water into the intestines. Because they both treat constipation, one of the most common side effect for each is diarrhea. However, Linzess also has other commonly reported side effects such as abdominal pain and flatulence.
While Trulance comes in an oral tablet in one strength, Linzess is available as an oral capsule in three different strengths. However, not enough studies have been conducted to directly compare the effectiveness of the two drugs. This is due to the relatively recent approval of Trulance on the market.
Both Trulance and Linzess can only be obtained with a doctor’s prescription. Therefore, it is important to only take these medications with guidance from a doctor. The information provided here is for educational purposes and should be discussed with a healthcare professional to determine the best treatment option for you.
Linzess (Linaclotide) For IBS With Constipation Or Chronic Idiopathic Constipation Now Available, USA
Linzess (linaclotide), a medication for irritable bowel syndrome (IBS) with constipation or chronic idiopathic constipation is now available in American pharmacies, Ironwood Pharmaceuticals Inc. and Forest Laboratories Inc announced.
The FDA (Food and Drug Administration) recently approved the once-daily oral capsule, Linzess, for adults of either sex who suffer from IBS-C (IBS with constipation) or CIC (chronic idiopathic constipation).
Linaclotide is the only FDA-approved GC-C (guanylate cyclase-C) agonist that acts locally in the gut. Ironwood Pharmaceuticals says this is the first new prescription option for adults with these disorders in over six years.
About Linzess (linaclotide)
Linzess (linaclotide) is the “first and only guanylate cyclase‐C (GC‐C) agonist approved by the FDA for the treatment of both irritable bowel syndrome with constipation (IBS‐C) and chronic idiopathic constipation (CIC) in adults”, according to Ironwood Pharmaceuticals.
Linzess is taken orally, in capsule form, once a day. It helps relieve the pain and constipation linked to IBS-C and constipation and hard stools experienced by patients with CIC.
The recommended doses are:
- 290 mcg for IBS‐C patients
- 145 mcg for CIC patients
You should take Linzess at least thirty minutes before breakfast (or your first meal of the day).
Scientists believe Linzess works in two ways “Linzess binds to the GC‐C receptor locally, within the intestinal epithelium. Activation of GC‐C results in increased intestinal fluid secretion and transit and a reduction in visceral pain, which is thought to be mediated by decreased activity of pain‐sensing nerves. The clinical relevance of the effect on pain fibers in nonclinical studies has not been established.”
In randomized, placebo-controlled Phase III human studies involving over 2,800 adults, Linzess was shown to alleviate abdominal pain in patients with IBS-C, as well as increasing bowel movement frequency among those with CIC and IBS-C.
Abdominal pain relief was reported during the first week of treatment and was maintained during the whole of the 12-week treatment period. Maximum effect on constipation was seen during week two, and on abdominal pain at weeks 6 to 9.
A subset of patients who had been on Linzess were switched over to placebo during the trial. They reported that their symptoms went back to pretreatment levels within seven days. Some placebo patients were switched over to Linzess and reported improvements soon after taking the medication.
Linzess should not be taken by patients up to the age of six years. The medication should be avoided in patients aged from 6 to 17 years. Animal studies showed that a clinically relevant adult dose of linaclotide caused deaths in juvenile mice. No trials have been carried out on children. The most commonly reported side effect associated with Linzess treatment was diarrhea.
Linzess is being co-promoted by Ironwood and Forest in the USA. Linaclotide, which was also approved in the European Union, will be marketed under the brand name Constella through a licence agreement between Ironwood and Almirall S.A. The development and commercialization in Japan and other Asian markets will be done via agreements between Ironwood and Astellas Pharma Inc. and AstraZeneca.
Irritable Bowel Syndrome with Constipation
Up to 13 million people are thought to have irritable bowel syndrome with constipation (IBS‐C) in the USA. It is a chronic functional gastrointestinal disorder. IBS‐C symptoms can be severe enough to seriously undermine a patient’s ability to properly carry out daily living duties.
Patients typically suffer recurring abdominal discomfort or pain, constipation, hard or lumpy stools in over 25% of their bowel movements, and soft/watery stools in less than 25%.
Ironwood says there are very few approved therapies for IBS‐C available today.
Chronic Idiopathic Constipation
CIC (chronic idiopathic constipation) is thought to affect up to 35 million Americans today. It is a functional gastrointestinal disorder in which the sufferer has fewer than three bowel movements each week for at least three months.
CIC patients may also have a sensation of incomplete evacuation after going to the toilet, as well as hard stools.
Written by Christian Nordqvist
Drug Injury Watch
Here Are Some Of The “Findings” From An April 26, 2016 Document Which Seems To Have Disappeared Only Two Days Later
(Posted by Tom Lamb at DrugInjuryWatch.com)
UPDATE: “Synergy Petitions FDA to Update Linzess Labeling” (FDA News, 3/2/18)
In a citizen’s petition to the FDA, Synergy Pharmaceuticals urged the FDA to require a revision of the approved package insert of Ironwood Pharmaceutical’s irritable bowel syndrome medication Linzess (linaclotide).
Synergy claimed the Linzess package insert fails to provide adequate information for its use because the incidences of adverse effects in its clinical trials are unclear or misrepresented….
UPDATE: “Ironwood and Allergan Announce Supplemental New Drug Application for 72 mcg Linaclotide in Chronic Idiopathic Constipation Has Been Accepted for FDA Review” (June 9, 2016 Press Release issued by Allergan plc; Ironwood Pharmaceuticals)
This morning (4/28/16) my interest was easily piqued by this Google Alert:
Uncovered: Safety Issues Linked With Ironwood’s Drug, Linzess
Ironwood’s constipation drug, Linzess, is a primary suspect in at least 7 deaths, 85 hospitalizations, 16 disabilities, all in just 3 years since its launch in …
When I clicked through to that article on the Seeking Alpha website, however, I found this notification (accessed 4/28/16, 10:10 am New York time):
- This article has been removed at the request of the author.
Intrigued, I put that article title into a search engine and quickly found online this 65-page PDF document: “Uncovered: fatal safety issues linked with Ironwood’s drug, Linzess” (accessed 4/28/16, 10:15 am New York time). A little while later I decided it might be prudent to “Save” this PDF file given what I had read on the Seeking Alpha site earlier.
And I am sure glad I did so — because when I started to write this article at about 4:00 pm and tried to access the online PDF version of this April 26, 2016 Phase Five Research analyst report about Linzess, I saw that it was no longer available at the URL where I found it this morning (but perhaps it will be available when you read this article).
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With that background and/or caveat, I want to share with you some of what I found in this analyst report — as it appeared online this morning — which information suggests that there might be an FDA recall of Linzess for safety reasons.
- constipation drug, Linzess, is causing severe and fatal adverse events – Our research has uncovered Linzess (linaclotide) to be the primary suspect in at least 7 deaths, 85 hospitalizations, 16 disabilities and 10 cases of adverse events which required intervention, all in just 3 years since its launch in 2013. Backed by FDA case files, we believe that the findings outlined in this report will lead to the removal of Linzess from the market. We have been in discussion with the FDA’s Division of Gastroenterology and Inborn Errors Products representatives and shared our findings with them.
- Linzess is the most dangerous drug among Irritable Bowel Syndrome (IBS) and Chronic Idiopathic Constipation (CIC) Drugs – According to the evidence we have gathered, Linzess is by far the most harmful drug among any other IBS and CIC drug across any parameter, including all serious outcomes. In fact, our research indicates that Linzess carries a substantially greater risk even when compared to Lotronex, an IBS drug that was taken off the market in 2000 due to severe safety concerns after causing deaths, dozens of hospitalizations, bowel surgeries and disabilities.
- Contrary to IRWD’s claims, Linzess’s side effects are not limited to the gastrointestinal (GI) tract – We present evidence that Linzess is causing previously unknown, unreported and unlabeled severe systemic adverse events, including documented cases of rapid weight gain, renal failure, seizures and strokes. Since IRWD states that Linzess is confined to the GI tract in its mechanism of action, such systemic adverse events were unexpected, and likely remained undetected in the post-market setting.
Be assured I will be watching for more developments concerning this April 26, 2016 Phase Five Research analyst report about Linzess.
If you happen to know or learn anything about the circumstances of this rather mysterious analyst report, please share it with us by posting a Comment below. (Or, if you prefer, you can use the Email Me link in the right sidebar of this Drug Injury Watch blog.)
Linzess (linaclotide) was approved by the FDA in 2012 for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation.
I wrote previously about the safety profile of Linzess in this August 2014 article, “July 2014 Boxed Warning For Linzess: Irritable Bowel Syndrome / Constipation Drug May Be Unsafe And Cause Diarrhea In Children”.
What, if anything, do you think will the FDA do next as regards Linzess?
DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects (All website content by attorney Tom Lamb)
Drug Injury Case Evaluation – Free. Confidential. No Obligation. (Case review done by attorney Tom Lamb)
FDA has approved a new lower dose of Linzess (linaclotide), available from Allergan, giving clinicians more flexibility in managing adult patients with chronic idiopathic constipation (CIC).
Indications: Linzess is a once daily capsule designed to relieve the abdominal pain and constipation associated with irritable bowel syndrome accompanied by constipation (IBS-C). It can also relieve the infrequent stools, hard stools, and incomplete evaluation that accompanies chronic idiopathic constipation. While the 145 mcg dose is intended for CIC patients, the 72 mcg dose has been approved for use in CIC depending on individual patient presentation or tolerability.
Dosage and administration: The new 72 mcg formulation means the drug can be prescribed in 3 doses: 72, 145, and 290 mcg. Both the 72 and 145 mcg doses are intended for patients with CIC while the 290 mcg formulation is designed to treat IBS-C.
Adverse reactions: The most common adverse reactions (≥2%) reported in IBS-C or CIC patients are: diarrhea, abdominal pain, flatulence and abdominal distension.