Viberzi (eluxadoline) is a medicine that stops diarrhea by slowing down muscle contractions in the intestines. Unfortunately, it may also slow down the flow of digestive juices from the pancreas into the intestines.
In patients without a gallbladder, this may cause digestive juices to back up into the pancreas and cause severe inflammation (pancreatitis). In some cases, pancreatitis occurs after just 1 or 2 doses of Viberzi.
The 2 people who died after taking Viberzi did not have gallbladders. The FDA noted that Viberzi should not be used by patients without gallbladders due to the increased risk of pancreatitis and death.
One death was associated with pancreatitis and one death was associated with sphincter of Oddi spasm, a life-threatening medical condition that stops the flow of digestive juices into the intestines.
According to the FDA Safety Communication:
The case of death from pancreatitis was characterized by acute, severe abdominal pain, nausea, and vomiting within 60 minutes of taking a single dose of Viberzi. The cause of death associated with sphincter of Oddi spasm reported severe abdominal pain and vomiting shortly after taking the first dose of Viberzi.”
Both patients were hospitalized for treatment. Notably, the patient who experienced pancreatitis died within 3 days of taking their first dose of Viberzi. The FDA warns that pancreatitis and death can occur in just 1 or 2 doses of Viberzi, especially in patients without a gallbladder.
Before starting Viberzi, the FDA recommends that patients tell their doctor if they do not have a gallbladder or have had pancreatitis, sphincter of Oddi dysfunction, liver problems, chronic constipation, bowel blockages, or drink more than 3 alcoholic beverages per day.