Viberzi (eluxadoline) is approved for use in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). Viberzi works by activating opioid receptors in the gut to decrease bowel contractions, which leads to less diarrhea. It can also help to ease stomach-area or abdomen pain and improve stool consistency.
In March 2017 this document was issued, “FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder”.
According to this March 2017 FDA document:
- Hospitalizations related to pancreatitis, including deaths, have been reported with Viberzi in patients who do not have a gallbladder.
- Hospitalizations related to pancreatitis have also been reported in patients with a gallbladder.
- Symptoms of pancreatitis can occur after just one or two doses of Viberzi.
In more detail, from the Data Summary part of this Viberzi FDA Drug Safety Communication:
From May 2015, when Viberzi was first approved, through February 2017, FDA received reports of 120 serious cases of pancreatitis or death in the FDA Adverse Event Reporting System (FAERS) database. Seventy-six of these cases resulted in hospitalization, of which two patients died….
As of February 2017, two deaths considered to be associated with Viberzi have been reported to FDA. Both deaths occurred in patients who did not have a gallbladder. One death was associated with pancreatitis and the other death was associated with sphincter of Oddi spasm. 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 case 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 the initial Viberzi dose.
We are investigating possible Viberzi lawsuits against Allergan, the responsible drug company, for injury or death involving serious side effects such as pancreatitis and sphincter of Oddi spasm.[View article at original source]