Here Are Some Of The "Findings" From An April 26, 2016 Document Which Seems To Have Disappeared Only Two Days Later
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).
Strictly Confidential, No Obligation
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.
- [Ironwood (IRWD)’s] 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. [Note: bolded text and color per the original document; footnotes omitted]
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?