FDA Warns of Anti-Diarrhea Medication Viberzi Amid Severe Pancreas Inflammation Concerns

Viberzi (sold by Allergan) is a medication used to treat irritable bowel syndrome in adults suffering primarily with the symptom of diarrhea. In March 2017, the Federal Drug Administration (FDA) issued a warning that Viberzi should not be used in patients without a gallbladder. The warning stems from reports of pancreatitis occurring in some of these individuals – those without a gallbladder and some with a gallbladder.

Pancreatitis is a condition that can be life-threatening and involves the inflammation of the pancreas, an organ responsible for producing digestive hormones and enzymes. Viberzi, surprisingly, has been reported to the FDA as responsible for an acute increase in pancreatitis conditions. The agency received 120 reports of pancreatitis or death from May 2015 to February 2017 in those who used the drug.

What is Viberzi?

Prescribed as a twice-daily pill, Viberzi (eluxadoline) is given to adults with Irritable Bowel Syndrome (IBS) and suffering from diarrhea as a result. It is a Schedule IV controlled substance. The drug slows down muscle contractions to prevent the occurrence of diarrhea by activating opioid receptors in the intestines.

Viberzi can also reduce pain in the abdomen and stomach area and enhance the consistency of stool. The FDA now recommends patients without a gall bladder cease taking this dangerous drug immediately and seek emergency medical care if they experience new or deteriorating symptoms (regardless of whether nausea or vomiting are involved) including:

• Pain in the abdomen or stomach area
• Pain in the abdomen that moves to the shoulder or back
• Pain in the upper right portion of the stomach area

The issue with Viberzi

Although slowing down intestinal muscle contractions can effectively treat an issue with diarrhea, it can also affect other muscles that are necessary to control the flow of bile and pancreatic juices. Individuals without a gallbladder are more likely to have their pancreas become inflamed due to the backup of digestive juices into the organ. This is referred to as acute pancreatitis.

The risk based on reports

Of the 120 reports linking Viberzi to serious pancreatitis or death between May 2015 and February 2017, 76 were hospitalized and 2 died. Of these, 56 individuals did not have gallbladders, including the 2 individuals who died. The conclusion has been made that only one or two doses of the drug can create symptoms of pancreatitis in those without gallbladders. A person with severe pancreatitis may experience organ failure within a 24-hour period.

The FDA’s warning prior to commencing treatment with Viberzi

Prior to beginning treatment with Viberzi, the FDA warns that patients should inform their healthcare provider if they now have or previously had any of these conditions:

• No gallbladder
• Inflammation of the pancreas
• Severe liver problems
• Possible or real blockage in the gallbladder or a sphincter of Oddi problem
• Chronic constipation
• Bowel blockage

At McGowan, Hood, Felder & Phillips, LLC, our product liability and dangerous drug attorneys have extensive experience handling cases for our clients who have suffered serious injury. If you or a loved one has taken a prescribed drug such as Viberzi and endured hardship and suffering as a result, including the development of pancreatitis, we can help you seek the compensation you deserve for your injuries, pain and suffering, and medical expenses.

To schedule a free appointment about your case, call our law office today at 803-327-7800 or send us a request through our contact form.