The FDA is warning that the irritable bowel syndrome (IBS) medication Viberzi (generic: eluxadoline) may increase the risk of pancreatitis in patients with certain risk factors.
Free Confidential Lawsuit Evaluation: If you or a loved one got pancreatitis after taking Viberzi, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What is Viberzi?
Viberzi is an 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.
What’s the Problem?
The U.S. Food & Drug Administration (FDA) issued a drug safety communication on March 15, 2017, indicating that Viberzi could cause severe pancreatitis resulting in hospitalization or death in patients who had their gallbladders removed.
How Many Reports of Pancreatitis have been linked to Viberzi?
Although Viberzi has been on the market 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 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 had pancreatitis or other serious side effects from Viberzi, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.