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FDA Warns Patients Without a Gallbladder to Beware Viberzi

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According to the FDA, if you have gone through a surgical procedure to remove your gallbladder, you shouldn’t be using Viberzi (eluxadoline), a prescription drug treatment for irritable bowel syndrome (IBS).

In a recent drug safety communication, the FDA warned that Viberzi can increase risk of serious pancreatitis in patients without a gallbladder. When taking this medication, this patient population should watch out for symptoms like stomach-area or abdomen pain, or pain in the upper right side of the stomach or abdomen that moves into the back or shoulder. These could be signs of pancreatitis, which can cause hospitalization and even death.

Viberzi Approved as a Treatment for IBS in 2015

The FDA approved Viberzi for the treatment of IBS in May 2015. IBS is a digestive disorder that affects the large intestine or colon. It causes symptoms like abdominal pain, nausea, vomiting, gas, diarrhea, constipation, and bloating. It is a chronic condition that can seriously impair a patient’s quality of life.

According to the International Foundation for Functional Gastrointestinal Disorders, IBS affects between 25 and 45 million people, and tends to affect women more often than men. The cause is unknown, but current research suggests that in people with IBS may have abnormalities in the nervous system that communicates between the brain and the gut. These abnormalities may cause the colon muscles to move too fast or too slow, resulting in IBS symptoms.

Viberzi was designed to activate receptors in the nervous system to lessen bowel contractions. Patients with IBS take an oral dose twice daily with food to help reduce their symptoms.

The clinical trials that were used to gain FDA approval of the drug involved 2,425 patients who either received Viberzi or a placebo over a period of only 26 weeks. Results of these trials showed that, at least in the short term, the drug was more effective at reducing abdominal pain and improving stool consistency than a placebo.

Viberzi Linked with Two Patient Deaths

The FDA stated in its safety communication that between May 2015 when Viberzi was approved and February 2017, it had received 120 reports of serious pancreatitis or death potentially related to the drug. A total of 68 of the patients reported their gallbladder status, and 56 of those didn’t have a gallbladder.

Of the 120 adverse event reports, seventy-six of the patients were hospitalized, and two of them died. Neither of the patients who died had a gallbladder. In one of the deaths, the patient suffered from pancreatitis, which is an inflammation of the pancreas. In the other, the patient’s death was associated with an Oddi spasm of the sphincter. The sphincter of Oddi is the valve around the opening between the pancreas and gallbladder (or liver) and the small intestine. Bile flows through a duct controlled by this valve. An Oddi spasm means that the valve clamps shut and cannot relax, or becomes narrowed because of inflammation.

In patients without a gallbladder, symptoms of pancreatitis or an Oddi spasm may occur after just two doses of the drug. Serious cases can also occur with prolonged use of the medication.

The FDA warned physicians not to prescribe Viberzi to patients without a gallbladder and to consider alternative treatments instead.

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  1. Esther says:
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    Just removed my gallbladder should I change my diet? Can I use castor oil or freshen for constipation?

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