Safety Alerts & Recalls

What does this mean?

If you have IBS-D, and are taking Viberzi, you should talk to your healthcare provider about how to control your symptoms of irritable bowel syndrome with diarrhea (IBS-D), particularly if you do not have a gallbladder. The gallbladder is an organ that stores bile, one of the body’s digestive juices that helps in the digestion of fat. Your healthcare provider can help you weigh the benefits versus the potential risks of this medicine.

Stop taking Viberzi right away and get emergency medical care if you develop new or worsening stomach-area or abdomen pain, or pain in the upper right side of your stomach-area or abdomen that may move to your back or shoulder. This pain may occur with nausea and vomiting. These may be symptoms of pancreatitis, an inflammation of the pancreas an organ important in digestion; or spasm of the sphincter of Oddi, a muscular valve in the small intestine that controls the flow of digestive juices to the gut.

Talk to your healthcare provider if you have questions or concerns about Viberzi or any of your medicines.

FDA Warns about Increased Risk of Serious Pancreatitis with Irritable Bowel Drug Viberzi (eluxadoline) in Patients without a Gallbladder

The U.S. Food and Drug Administration (FDA) is warning that Viberzi (eluxadoline) should not be used in patients who do not have a gallbladder. Viberzi is a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D).

An FDA review found these patients who take Viberzi and who do not a gallbladder have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. The FDA is working with the Viberzi manufacturer, Allergan, to address these safety concerns.

For more information, please visit: more information here

Source: FDA
Publication Date: 2017-07-31
Last Updated: 2017-07-31

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