A new Viberzi lawsuit filed in Pennsylvania claims Allergan USA withheld important safety information from patients and doctors in the United States.
Specifically, the fact that Viberzi increases the risk for pancreatitis in patients without a gallbladder
According to a complaint filed in the U.S. District Court, Eastern District of Pennsylvania, Mary Anne LaPorte began taking Viberzi to treat irritable bowel syndrome on December 2, 2016. Previously, she had undergone a cholecystectomy to remove her gallbladder. (Case 5:18-cv-05092-CFK)
LaPorte was hospitalized with pancreatitis just two days later. Her doctor discontinued Viberzi after confirming the diagnosis.
“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.”
Among other things, LaPorte claims Allergan knew or should have known that Viberzi could cause pancreatitis in patients without a gallbladder.
“Prior to December 2016, Defendant had received numerous spontaneous reports of acute pancreatitis and/or SOD, the vast majority of which were dosed at 75 mg, indicating use by patients with prior cholecystectomies,” the Viberzi lawsuit charges.
“Prior to December 2016, the European Medicines Agency (EMA) informed Defendant that it would contraindicate Truberzi (the company’s name for Viberzi in Europe) use in patients without a gallbladder,” it continues.
The U.S. Food & Drug Administration (FDA) approved Viberzi in May 2015. At the time, the drug’s label recommended a 75 mg dose for cholecystectomy patients.
In March 2017, however, the FDA advised doctors not to prescribe Viberzi to patients without a gallbladder. Apparently, the agency had received 120 reports of serious pancreatitis or death associated with the medication.
“Among the 68 cases that reported gallbladder status, 56 cases of pancreatitis or death occurred in patients who do not have a gallbladder,” the agency noted. “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.”
Furthermore, 76 patients required hospitalization, including two who died. Neither of those patients had a gallbladder.
A month later, Allergan finally updated the Viberzi label to include a contraindication for patients without a gallbladder.
Before starting Viberzi, patients should tell their health care professional if they have:
Patients should stop taking Viberzi right away and get emergency medical care if they develop: