Basis of Viberzi Lawsuit
The Viberzi lawsuit is against the manufacturer for failing to warn that Viberzi could cause acute pancreatitis. Viberzi is manufactured by Allergan, Inc. The Viberzi lawsuit alleges that Allergan failed to warn both patients and prescribing doctors that Viberzi could suddenly induce acute pancreatitis. Patients put on Viberzi who do not have a gallbladder are at a significantly higher risk of developing acute pancreatitis.
Viberzi, also known by its chemical name eluxadoline, is utilized for the treatment of irritable bowel syndrome with diarrhea (IBS-D). The FDA approved Viberzi for the treatment of irritable bowel syndrome in adults on May 27, 2015. Viberzi works by decreasing bowel contractions, which leads to less diarrhea. Viberzi works by influencing the brain-gut signaling through the endogenous opioid system. Like opioids, Viberzi decreases gut motility and secretions.
Viberzi Side Effects
Adverse reactions to Viberzi can happen soon after the first dose is administered. The first patient reported to have died from Viberzi started to show symptoms within one hour of the first dose being administered. The first Viberzi side effects the patient experienced were severe abdominal pain, nausea, and vomiting. The patient’s pancreatitis progress and the patient ultimately died three days after the first dose of Viberzi.
Sphincter of Oddi Spasm
The second reported death caused by Viberzi was due to sphincter of Oddi spasms. Again, this patient also experienced severe abdominal pain and vomiting shortly after taking their first dose of Viberzi. Patients with a known history of sphincter of Oddi spasm were excluded from all Viberzi trials. This was based on prior data demonstrating that patients experiencing sphincter of Oddi spasm are sensitive to opioids and can have a higher incidence of abdominal pain and pancreatitis after exposure to opioid-containing medications.
FDA Action Regarding Viberzi
Safety Announcement Viberzi-Induced Pancreatitis
On March 15, 2017, the FDA announced a drug safety communication regarding Viberzi. The FDA warned that in patients without a gallbladder, the IBS drug Viberzi increases the risk of serious pancreatitis. The FDA conducted a review and found that Viberzi-induced pancreatitis was so severe that was resulted in extended hospitalizations and death! The FDA believes that Viberzi-induced pancreatitis could be the result of how Viberzi causes the certain muscles in the small intestine to spasm.
Label Change: Contraindicated in Patients Without a Gallbladder
In April of 2017, the warning label for Viberzi was updated to include that Viberzi is contraindicated in patients without a gallbladder, because of an increased risk of pancreatitis or sphincter of Oddi spasm.
Scientific Articles on Viberzi
The authors conclude that Viberzi studies to date have not been able to demonstrate a significant improvement in abdominal pain at US FDA and EMA endpoints.
The authors note that the United States Food and Drug Administration approved Viberzi for the treatment of diarrhea-predominant irritable bowel syndrome despite cases of pancreatitis in early stage trials. The study investigates adverse events reported to the FDA from January through September of 2016. In this nine month time period there were 597 adverse events reported to the FDA on Viberzi. Over half of the patients that experienced Viberzi-induced pancreatitis were hospitalized. The authors recommend that the risk-benefit ratio of Viberzi be re-evaluated in light of the significant adverse events.
The authors conclude that Viberzi “has been associated with serious adverse effects such as sphincter of Oddi spasm and pancreatitis. Sphincter of Oddi spasm occurred in patients without a gallbladder, and pancreatitis was associated with excessive alcohol use and biliary disorders. Therefore, it is important to consider the risk-benefit of using eluxadoline in patients without a gallbladder or who consume excessive alcohol.”
The authors note that the most common adverse symptoms associated with Viberzi were abdominal pain, nausea, vomiting, and constipation. All of the symptoms that the authors noted could be caused by acute pancreatitis. The most commonly reported serious adverse event associated with Viberzi was pancreatitis. The authors also noted that one patients suffered colon ischemia. It was observed that patients treated with Viberzi who did not have a gallbladder experienced the highest rate of adverse events. Most adverse events with Viberzi were observed within the first two weeks of the patient starting Viberzi.
The study notes that adverse events consistent with pancreatitis and sphincter of Oddi spasms were observed in patients taking Viberzi.
The authors noted higher adverse events in patients taking Viberzi who did not have a gallbladder. The study concluded that there “may also be potential for increased risk of pancreatitis with [Viberzi], especially associated with heavy alcohol use.” It was recommended that Viberzi be contraindicated in patients with a history of pancreatitis, structural diseases of the pancreas, known or suspected sphincter of Oddi dysfunction, alcoholism, or alcohol abuse. Furthermore, patients should avoid chronic or acute excessive alcohol consumption while taking Viberzi.
The authors note that Viberzi “was associated with increased occurrence of sphincter of Oddi spasm and biliary pancreatitis.” The authors then advocated that “long-term studies and comparative studies with pharmacotherapy, as well as elucidation of the underlying mechanisms of action, are needed.”
Safety analysis of two phase III clinical trials that lasted 26 weeks and 52 weeks. Serious adverse events included pancreatitis in patients with biliary sludge or excessive alcohol use defined as greater than three drinks per day, and sphincter of Oddi dysfunction, the latter of which exclusively occurred in patients without a gallbladder.
If you or a loved one have experienced pancreatitis after taking Viberzi contact the Hollis Law Firm today at 1-800-701-3672. One of our Viberzi lawsuit intake specialist are standing by. All potential Viberzi lawsuits are investigated and evaluated for free. The Hollis Law Firm works on a contingency fee basis, which means we don’t get paid unless you get paid. Call 1-800-701-3672 for a free Viberzi lawsuit consultation today.
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