Federal drug regulators issued a new warning this week about the potential side effects of Viberzi, a drug approved to treat irritable bowel syndrome (IBS), which may increase the risk of serious cases of pancreatitis in some patients.
The FDA issued a Viberzi drug safety communication on March 15, indicating that its own review of the drug suggests that patients who have had their gallbladder removed could experience cases of pancreatitis that are serious enough to cause hospitalization or death.
Although it was just approved less than two years ago, Viberzi has already been linked to at least two deaths and 120 reports of serious pancreatitis.
Viberzi (eluxadoline) is manufactured by Allergan and was introduced in May 2015 for the treatment of IBS with diarrhea. It is a controlled substance similar to an opioid and can be addictive. It works by activating opioid receptors in the gut, which decreases bowel contractions, reducing incidents of diarrhea and sometimes alleviating abdominal pain.
The FDA indicates that it has received 120 reports of serious pancreatitis or death through the FDA Adverse Event Reporting System since the drug was first approved. In 76 cases, the person was hospitalized, and two of those patients died. The FDA found that the cases of serious pancreatitis seemed to occur after only one or two doses, however they also occurred in some patients after prolonged use.
Of the cases reported, 68 included details on the patient’s gallbladder status. Of those cases, 56 involved patients without a gallbladder. Both of the deaths occurred in patients who did not have a gallbladder.
One of the deaths was associated with severe pancreatitis, during which the victim suffered acote, severe abdominal pain, nausea and vomiting within an hour of taking Viberzi. They died within three days of their first Viberzi dose, the FDA notes.
The other patient’s death was linked to spasms of their sphincter of Oddi, which controls the flow of pancreatic juices and bile. Sphincter of Oddi problems have been linked to the use of opioids in the past. That patient also began suffering abdominal pain and vomiting after their first dose of Viberzi.
“Patients should talk to your health care professional about how to control your symptoms of irritable bowel syndrome with diarrhea (IBS-D), particularly if you do not have a gallbladder,” the FDA advises. “Health care professionals should not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients.”
The FDA notes that it is working with Allergan to address its safety concerns. It is also urging doctors and patients to report Viberzi problems to the FDA MedWatch adverse event reporting program.