According to a U.S. Food and Drug Administration (FDA) Safety Communication, they provide a Viberzi FDA warning advising of the risks for developing serious pancreatitis with the irritable bowel drug in patients without a gallbladder.

Persons with IBS who have had their gall bladder removed are advised to avoid taking Viberzi. The Viberzi FDA warning advises that “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.”

They also add that “Health care professionals should not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients.”

Symptoms of pancreatitis associated with Viberzi medication may include some of the following:

• Fever
• Loss of appetite
• Nausea
• Back pain
• Abdominal pain
• Fast heart rate
• Sweating
• Vomiting
• Weight loss

Overview: Viberzi FDA Warning

According to the FDA, Viberzi (eluxadoline) is a medication prescribed to treat IBS-D, also known as irritable bowel syndrome with diarrhea. However, they advise that patients without a gallbladder  should not be prescribed the medication.

The gallbladder is an organ of the body that helps with fat digestions and the storage of bile, the body’s digestive juices that help with fat digestion.

Based off an FDA review, the agency found that there are serious risks for developing severe pancreatitis for patients without a gallbladder that can lead to hospitalization or death. The FDA advises that they are working with the drug’s manufacturer, Allergan, to “address these safety concerns,” but that pancreatitis may come about due to a “spasm of a certain digestive system muscle in the small intestine.”

Whether the consumer has a gallbladder or not, however, with any new or worsening stomach/abdominal pain the FDA advises a patient to stop taking Viberzi medication and to get medical care right away. Pain may be located in the abdomen or right side of the stomach and move to the shoulder to back area.

In addition to pain there may also be vomiting and nausea.

While these are some of the symptoms of pancreatitis (inflammation of the pancreas), this may also be a symptom of the spasm of the sphincter of Oddi (the muscular valve in the small intestine that is responsible for the “flow of digestive juices to the gut.”)

The FDA’s announcement maintains that patients who had taken Viberzi medication and were hospitalized or died did so post a gallbladder removal procedure, cholecystectomy.

Viberzi and Pancreatitis

The Viberzi FDA warning says that they have received almost 120 reports of patients who had taken Viberzi and developed pancreatitis. In fact, seventy-six patients required hospitalization after taking Viberzi medication, of which there were also fifty-six patients who had undergone a cholecystectomy procedure.

According to the FDA report, two patients of the 120 Viberzi medication reports received died after they had taken the drug. During their time of death, they were taking a 75 mg dose of Viberzi medication. The FDA advises that pancreatitis may come about after simply two doses of Viberzi.

The Viberzi FDA warning advises that any patient with a variety of issues should not to take Viberzi, including:

• Chronic constipation
• Liver disease
• Pancreatic issues
• Intestinal obstruction
• Digestive problems caused by sphincter of Oddi muscle valve
• Gallbladder obstruction
• History of cholecystectomy (gallbladder removal)
• Drinking more than three alcoholic drinks a day