Severe Cases Of Pancreatitis And Sphincter Of Oddi Spasm Reported Even After Just The First Dose Of Viberzi, With Some Resulting In Patient Deaths
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".
The following month, in April 2017, the drug company Allergan released a new Viberzi drug label, the details of which are set forth in this earlier article, "FDA Warns of Serious Pancreatitis Risk in Some Patients Taking Viberzi", on our Drug Safety Developments blog.
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.
According to the above-mentioned 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. Some cases of serious pancreatitis or death also reported sphincter of Oddi spasm (n=6) or abdominal pain (n=16).
Among the 84 cases that reported a time to onset of the adverse event, serious cases of pancreatitis or death occurred after one or two doses of Viberzi (n=48). Serious cases of pancreatitis also occurred subsequently with prolonged use (n=36).
Among the 68 cases that reported gallbladder status, 56 cases of pancreatitis or death occurred in patients who do not have a gallbladder. The majority of patients (n=44/56) received the currently recommended dosage of Viberzi (75 mg) for patients who do not have a gallbladder. Of the 56 cases in patients who do not have a gallbladder, 21 reported that the patient did not abuse alcohol and 35 did not report the patient’s alcohol use status.
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.
Of course, we will continue to monitor the medical literature and regulatory actions for developments concerning Viberzi side effects such as pancreatitis and sphincter of Oddi spasm.
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