Kristin on last man standing weight gain11/12/2022 ![]() 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". Linzess (linaclotide) was approved by the FDA in 2012 for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation. (Or, if you prefer, you can use the Email Me link in the right sidebar of this Drug Injury Watch blog.) 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. īe assured I will be watching for more developments concerning this ApPhase Five Research analyst report about Linzess. 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. 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.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. 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.We have been in discussion with the FDA’s Division of Gastroenterology and Inborn Errors Products representatives and shared our findings with them. Backed by FDA case files, we believe that the findings outlined in this report will lead to the removal of Linzess from the market. 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.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. Kristin on last man standing weight gain pdf#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.Īnd 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 ApPhase 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). 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).
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