Patients who don’t have a gallbladder should be aware that Viberzi dosing could potentially increase their risk of pancreatitis.

Viberzi was approved by the U.S. Food and Drug Administration (FDA) in May 2015 to treat irritable bowel syndrome with diarrhea. Allergan makes Viberzi, which has been linked to at least two deaths in patients, one who developed acute pancreatitis and whose death was associated with a spasm of the sphincter of Oddi. Both patients had previously had their gallbladders removed.

The patient who suffered pancreatitis and died passed away within three days of taking the first Viberzi dosing schedule.

The FDA issued a warning in early 2017 that patients who no longer had their gallbladders should not take Viberzi. As little as one or two doses of 75mg Viberzi tablets can cause an acute pancreatitis attack, warned the FDA.

The FDA said it received 120 reports of serious pancreatitis or death between May 2015 (when Viberzi was approved) through February 2017. Of the 68 patients who divulged the status of their gallbladders, 56 no longer had a gallbladder.

Viberzi Dosing and Pancreatitis

Viberzi controls diarrhea associated with irritable bowel syndrome by decreasing bowel contractions. Unfortunately, Viberzi might cause spasms of the sphincter of Oddi, a valve that is the muscular portion of the small intestine that regulates the flow of bile and pancreatic juices. If the spasms activate the digestive juices from the pancreas before they even enter the small intestine, the enzymes start to break down the pancreas, causing pancreatitis.

The pancreas is a large gland that releases insulin and glucagon into the bloodstream. As alluded to earlier, the pancreas also releases digestive enzymes into the small intestine to ensure complete digestion.

Acute pancreatitis means the pancreas has suddenly become inflamed and can range from mild stomach pain to a life-threatening illness. Severe cases can result in the gland bleeding, tissue damage, infection or the formation of cysts. The heart, lungs and kidneys also can be placed at risk because of severe pancreatitis.

The FDA advises patients who wish to take Viberzi to first tell their doctors if they have:

• No gallbladder
• Had a blockage of the gallbladder or a problem with the sphincter of Oddi
• Experienced an inflamed pancreas
• Serious liver problems
• A history of chronic constipation
• Had a bowel blockage
• A history of drinking more than three alcoholic beverages per day

Why patients who have no gallbladder appear to be at greater risk of pancreatitis when they take Viberzi is currently unknown. The gallbladder is a small hollow organ that stores bile, which is made by the liver. The gallbladder releases bile into the small intestine to help humans digest fatty foods.

People who need their gallbladder removed continue to live long, healthy lives, but may have difficulty digesting fatty foods and experience either temporary or chronic diarrhea. The liver continues to make bile, but more than 50 percent of patients who undergo gallbladder removal experience problems digesting fatty foods.