According to allegations raised in a product liability lawsuit filed against Allergan, side effects of Viberzi may place individuals without gallbladders at an increased risk of developing pancreatitis.
In a complaint (PDF) filed in in the U.S. District Court for the Eastern District of Pennsylvania on November 23, Mary Anne LaPorte alleges that the company knowingly withheld important safety warnings that individuals who previously had their gallbladder removed faced increased risks associated with the irritable bowel syndrome drug.
LaPorte indicates she started taking Virberzi in December 2016. However, just two days later she was hospitalized with severe pancreatitis, and remained in the hospital for two days. Doctors determined Viberzi side effects caused the development of her pancreas problems because she did not have a gallbladder.
As a result of the Viberzi pancreatitis complications, LaPorte continues to suffer serious health consequences and must undergo medical monitoring for the rest of her life, the complaint states.
The lawsuit alleges that the drug maker knew or should have known that use of Viberzi by individuals without gallbladders could cause acute pancreatitis, pointing to numerous spontaneous adverse event reports, the vast majority of which involved 75mg doses and use among individuals who previously underwent gallbladder removal.
“Despite their collective resources, Defendant failed to fully and adequately test or research Viberzi and its association with pancreatitis to the detriment of Plaintiff, Viberzi users, the public, the medical community and prescribing doctors,” according to the complaint. “Upon information and belief, Defendant failed to design and/or implement clinical trials that would capture and analyze data to determine the incidence of acute pancreatitis in those patients with and without gallbladders.”
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.
“An episode of pancreatitis increases a patient’s risk that she will later develop pancreatic cancer. Fear of developing pancreatic cancer subsequent to pancreatitis is reasonable,” the lawsuit states. “Plaintiffs remain at an increased risk for recurrent acute pancreatitis and/or chronic pancreatitis and pancreatic cancer, which she fears, and she continues to be monitored for health issues.”
Allergan now faces a growing number of 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.