According to allegations raised in a recently filed product liability lawsuit, Viberzi side effects caused a California woman to develop pancreatitis, indicating that the manufacturers of the irritable bowel syndrome (IBS) treatment failed to adequately warn consumers or the medical community about the potential risk.
The complaint (PDF) was filed last month by Erin Duncan, in the U.S. District Court for the Central District of California, naming the drug maker Allergan as the defendant.
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.
According to the lawsuit, Duncan took a single dose of Viberzi in September 2016, months before the warning was added. Prior to initiating the treatment, Duncan had her gallbladder removed, but indicates that she was not warned about the potential pancreatitis risk. The same day she received the dose, Duncan was admitted to the hospital, and diagnosed with pancreatitis.
“Prior to September 2016, Defendants knew or should have known that Viberzi use in patients without gallbladders could cause or was causally associated with acute pancreatitis,” according to the complaint. “[D]efendants had received numerous spontaneous reports of acute pancreatitis and/or SOD, the vast majority of which were dosed at 75mg, indicating use by patients with prior cholecystectomis (gallbladder removal).
By at least July 2016, drug regulators in Europe had already determined that Viberzi posed an unreasonable risk for individuals without a gallbladder, contraindicating use of the medication, which is marketed as Truberzi outside the U.S.
As a result of the Viberzi pancreatitis injury, Duncan was hospitalized for four days and indicates that she continues to suffer health problems. In addition, the lawsuit notes that an episode of pancreatitis significantly increases the risk of pancreatic cancer in the future.
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.
The FDA indicated in March 2017 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.
The Viberzi lawsuit filed by Duncan presents claims for failure to warn, defective design, negligence, negligent misrepresentation, and breach of warranty, seeking both compensatory and punitive damages.