Side effects of the irritable bowel syndrome (IBS) medication Viberzi (generic: eluxadoline) may include pancreatitis in patients who have had their gallbladder removed.
Free Confidential Lawsuit Evaluation: If you or a loved one were diagnosed with pancreatitis from Viberzi, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.
What’s the Problem?
The U.S. Food & Drug Administration (FDA) issued a Drug Safety Communication and is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasms of a certain digestive system muscle in the small intestine. As a result, we are working with the Viberzi manufacturer, Allergan, to address these safety concerns.
Although Viberzi has been on the market for less than 2 years, it has already been linked to at least two deaths and 120 reports of serious pancreatitis.
Viberzi is manufactured by Allergan and was approved by the FDA in May 2015 for the treatment of IBS with diarrhea. It is a controlled substance similar to an opioid and can be addictive. The drug works by activating opioid receptors in the gut, which decreases bowel contractions, reducing incidents of diarrhea, and alleviating abdominal pain.
FDA has received at least 120 reports of serious pancreatitis or death since it was first approved. In 76 cases, the person required hospitalization, and 2 of those patients died. The agency 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 120 cases reported, 68 included details on the patient’s gallbladder status. Of those, 56 involved patients without a gallbladder. Both deaths occurred in patients whose gallbladders had been removed.
One of the deaths was associated with severe pancreatitis, during which the victim experienced symptoms including severe abdominal pain, nausea, and vomiting within an hour of taking Viberzi. Both victims died within 3 days of their first dose of the drug, according to the FDA.
“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,” FDA said. “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 agency noted that it is working with Allergan to address safety concerns, and is urging doctors and patients to report Viberzi problems to the FDA MedWatch adverse event reporting program.
What is Viberzi?
Viberzi is a mu-opioid receptor agonist used in adults to treat irritable bowel syndrome with diarrhea (IBS-D). The drug is manufactured by Allergan and was approved by the U.S. Food & Drug Administration (FDA) on May 27, 2015.
How Does it Work?
Viberzi works by affecting opioid receptors in the digestive tract. The drug has a mixed action on 3 different receptor types - it activates 2 and inhibits 1 so as to get the desired relief of IBS-D symptoms without causing constipation.
How Many Reports of Pancreatitis have been linked to Viberzi?
Although Viberzi has been on the market for less than 2 years, it has been linked to at least 120 cases of severe pancreatitis, including 2 deaths. In 76 cases, the person was hospitalized, and 2 of those patients died from resulting complications.
How Long Did it Take Symptoms to Occur?
FDA found that most cases of serious pancreatitis associated with Viberzi seemed to occur after only one or two doses; however, some cases occurred in patients after prolonged use.
What are the Symptoms of Pancreatitis?
- Upper abdominal pain
- Abdominal pain that radiates to your back
- Abdominal pain that feels worse after eating
- Rapid pulse
- Tenderness when touching the abdomen
How Many Patients had Gallbladder Removal?
Of the 120 cases of pancreatitis associated with Viberzi, 68 included details on the patient’s gallbladder status. Of these, 56 involved patients had their gallbladder removed. Both deaths occurred in patients who did not have a gallbladder.
What Does the FDA Recommend?
“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,” 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.”
Has a Viberzi Class Action Been Filed?
Viberzi was only approved in May 2015 and the problems with the drug have only recently surfaced. It typically takes many years and thousands of injured consumers to come forward before class-action status is considered.
Have There Been Any Settlements?
No. The litigation is still in its very early stages and there have been no reports of Allergan offering settlements.
Do I Have a Viberzi Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Viberzi lawsuits. We are handling individual litigation nationwide and currently accepting new pancreatitis cases in all 50 states.
Free Case Evaluation: Again, if you were injured by Viberzi side effects, you should contact our law firm immediately by using the form below or dialing (866) 588-0600. You may be entitled to a settlement by filing a Viberzi lawsuit and we can help.