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March 15, 2017: FDA Warns Of Increased Viberzi Pancreatitis Risk In IBS Patients Without A Gallbladder

FDA Warns Of Increased Viberzi Pancreatitis Risk In IBS-D Patients Without A Gallbladder

In a Drug Safety Communication dated March 15, 2017, The U.S. Food and Drug Administration (FDA) warned that Viberzi (eluxadoline), should not be used in patients who do not have a gallbladder. The warning was made after an FDA review found that these patients 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 stated that it is working with the manufacturer of Viberzi, Allergan, to address these safety concerns.

What Is Viberzi?

Viberzi is medication prescribed to treat irritable bowel syndrome with diarrhea (IBS-D). Viberzi was approved in the U.S. in 2015.

FDA Viberzi Pancreatitis Risk Information For Patients

The FDA advised patients to talk to their health care professional about how to control their symptoms of irritable bowel syndrome with diarrhea (IBS-D), particularly if they do not have a gallbladder.

The agency also cautioned patients to “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.”

The gallbladder is a small sac-shaped organ that stores bile, one of the body’s digestive juices that helps in the digestion of fat. Bile is secreted by the liver and stored in the gall bladder before being released into the intestine.

Additional FDA patient advice can be found at FDA Viberzi Pancratitis Risk Information.

FDA Viberzi Pancreatitis Risk Information For Health Care Professionals

The FDA provided the following information for health care providers:

“Health care professionals should not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients. Hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder. Symptoms of pancreatitis have occurred with just one or two doses of Viberzi at the recommended dosage for patients who do not have a gallbladder (75 mg), and who do not consume alcohol.

Physicians can consider both over-the-counter (OTC) or FDA-approved prescription medicines to treat symptoms associated with IBS-D such as OTC bismuth subsalicylate (Kaopectate and Pepto-Bismol), OTC loperamide (Imodium), and prescription medicine diphenoxylate/ atropine (Lomotil) for diarrhea. Also consider OTC medicines for gas relief such as simethicone (Gas-X, Mylicon). Other FDA-approved prescription medicines for IBS-D include alosetron hydrochloride (Lotronex) and the antibiotic rifaximin (Xifaxan).

From May 2015, when Viberzi was first approved, through February 2017, FDA received 120 reports of serious cases of pancreatitis or death.* Among the 68 patients who reported their gallbladder status, 56 of them did not have a gallbladder and received the currently recommended dosage of Viberzi. Seventy-six patients were hospitalized, of which two patients died. These two patients did not have a gallbladder. Some cases of serious pancreatitis or death also reported sphincter of Oddi spasm (n=6) or abdomen pain (n=16) (see Data Summary).

*The cases were reported to the FDA Adverse Event Reporting System (FAERS)”

Viberzi Adverse Event Reporting

Patients and health care professionals can report side effects involving Viberzi (eluxadoline) to the FDA MedWatch program at FDA MedWatch.

Drug Side Effect Lawsuit Help

The Weinberg Law Firm is currently assiting individuals who have been injured after taking the IBS-D medication, Viberzi. If you or a loved one has experienced a Viberzi drug side effect, and you would like more information regarding you legal rights, please call The Weinberg Law Firm toll free at 977-934-6274. You can also submit the easy-to-use Free Legal Case Evaluation Form found on this page. To learn more about our firm, please see Drug Side Effect Lawsuits.

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Contact Weinberg Law Firm. You may also call us 24/7 at our toll free number, 1(877) 934-6274.