According to allegations raised in a recently filed product liability lawsuit, Allergan has failed to warn that side effects of Viberzi may cause pancreatitis for individuals who previously had their gallbladder removed.
In a complaint (PDF) filed this month in the U.S. District Court for the Southern District of New York, Herminia Rivera Martinez indicates that the irritable bowel syndrome drug should have been contraindicated for patients without gallbladders, due to the know risk or pancreatitis.
Martinez began taking Viberzi in May 2016, and indicates that she developed acute pancreatitis only a few days later, leaving her hospitalized for two days. Doctors linked her illness to Viberzi and she discontinued the medication. However, she has been left with continuing health problems and notes that she is now left at an increased risk of pancreatic cancer, which will follow her for the rest of her life, requiring regular medical monitoring, the lawsuit states.
“An episode of pancreatitis increases a patient’s risk that she will later develop pancreatic cancer,” the lawsuit states. “Fear of developing pancreatic cancer subsequent to pancreatitis is reasonable.”
Martinez had previously had her gallbladder removed, and the lawsuit indicates that Allergan knew Viberzi increases the pancreatitis risk for patients without a gallbladder, yet failed to provide adequate warnings for users or the medical community.
“Properly designed and executed clinical trials would have led the original May 2015 label to contraindicate use in patients without gallbladders,” according to Martinez. “Because the FDA did not have the benefit of data from adequately designed and executed clinical trials, it did not require contraindications in patients without a gallbladder.”
As a result of the failure to warn, Allergan now faces a growing number of similar Viberzi pancreatitis lawsuits being pursued by individuals nationwide, who allege they may have avoided problems if the initial warning labels had contraindicated use of the drug among those without a gallbladder.
Viberzi (eluxadoline) was introduced by Allergan 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.
In March 2017, the FDA issued a drug safety communication, warning about the link between Viberzi and pancreatitis among individuals who had their gallbladder removed. The next month, the manufacturer placed a new warning on Viberzi, contraindicating the drug for use in patients without a gallbladder.
At that time, the FDA indicated that it was aware of at least 120 reports involving serious pancreatitis from Viberzi, including a number of deaths, which were submitted through the FDA Adverse Event Reporting System since the drug was first approved. In 76 cases, the person was hospitalized, and the agency found that the cases of serious pancreatitis seemed to occur after only one or two doses.
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.