Related Article: Viberzi - Pancreatitis Side Effects Can Develop At Any Time While Taking This IBS Drug, According To FDA Safety Warning
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
In March of this year, the FDA released a Drug Safety Communication concerning the increased risk of serious pancreatitis in patients without a gallbladder who use the irritable bowel syndrome drug, Viberzi (eluxadoline).
Viberzi is a relatively new drug manufactured by Allergan used to treat irritable bowel syndrome in adults when the main symptom is diarrhea (IBS-D).
The FDA reported that pancreatitis developed as a result of taking Viberzi without having a gallbladder can result in hospitalization and even death:
From May 2015, when Viberzi was first approved, through February 2017, FDA received 120 reports of serious cases of pancreatitis or death.* Among the 68 patients who reported their gallbladder status, 56 of them did not have a gallbladder and received the currently recommended dosage of Viberzi. Seventy-six patients were hospitalized, of which two patients died. These two patients did not have a gallbladder. Some cases of serious pancreatitis or death also reported sphincter of Oddi spasm (n=6) or abdomen pain (n=16) (see Data Summary).
They also note that pancreatitis can develop in patients who have had as few as one or two doses of Viberzi. In fact, the two patients who died had only one dose of Viberzi, and "the patient who experienced pancreatitis died within 3 days of taking the initial Viberzi dose."
A new drug label was released on April 20, 2017, which added lack of a gallbladder to the contraindication section, as well as the following warnings:
5 Warnings and Precautions
5.1 Pancreatitis
(Additions and/or revisions are underlined)
Pancreatitis, with or without sphincter of Oddi spasm, has been reported in patients taking either the 75 mg or 100 mg dosage of VIBERZI, including serious cases resulting in hospitalization, primarily in patients without a gallbladder. Fatal cases have also been reported in patients without a gallbladder. VIBERZI is contraindicated in patients without a gallbladder. Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with VIBERZI and some developed symptoms after one to two doses.
In patients with a gallbladder, evaluate a patient’s alcohol intake prior to starting VIBERZI. Instruct patients to avoid chronic or acute excessive alcohol use while taking VIBERZI. Monitor for new or worsening abdominal pain that may radiate to the back or shoulder, with or without nausea and vomiting. Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of pancreatitis such as acute abdominal or epigastric pain radiating to the back or shoulder associated with elevations of pancreatic enzymes with or without nausea and vomiting.
5.2 Sphincter of Oddi Spasm
(Additions and/or revisions are underlined)
There is a risk of sphincter of Oddi spasm, resulting in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain (e.g., biliary-type pain) in patients taking VIBERZI. Postmarketing serious adverse reactions of sphincter of Oddi spasm with or without pancreatitis resulting in hospitalization have been reported, primarily in patients without a gallbladder. Most of the reported cases of serious sphincter of Oddi spasm occurred within a week of starting treatment with VIBERZI and some developed symptoms after one to two doses. VIBERZI is contraindicated inpatients without a gallbladder.
Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of sphincter of Oddi spasm such as acute worsening of abdominal pain,…
We will continue to monitor the medical literature for more information concerning the link between Viberzi use in patients without a gallbladder and severe pancreatitis.
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