FDA Issues New Warning for IBS Drug Viberzi

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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On March 15th, 2017, the FDA issued a drug safety communication for Viberzi (eluxadoline), which is used to treat irritable bowel syndrome with diarrhea (IBS-D).

The FDA warned that Viberzi can cause an increased risk of pancreatitis in patients without a gallbladder. A review found that these patients have an increased risk of developing serious pancreatitis that can result in hospitalization or death.

What are the signs/symptoms that patients should look out for?

If you or someone you know is taking Viberzi, you should seek medical attention if you experience (1) new or worsening pain in the stomach or abdomen area, or (2) pain in the upper right side of your stomach (that may move to your shoulder or back).

Symptoms of pancreatitis in patients without a gallbladder can occur just 1 or 2 doses of Viberzi.

How many cases have been reported to the FDA?

At this time the FDA has received 120 reports of serious cases of pancreatitis or death. Of the 120 reported cases 76 patients were hospitalized, and two without a gallbladder died.

This increased risk is mentioned in Viberzi’s package insert. The insert states the following: “monitor patients without a gallbladder for new or worsening abdominal pain, with or without nausea and vomiting, acute biliary pain with liver or pancreatic enzyme elevations; discontinue Viberzi and seek medical attention if symptoms develop.”

The FDA is also working with Allergan, the manufacturer of Viberzi, to address these safety concerns.

What does the FDA recommend prescribers do?

The FDA recommends that physicians, and those with prescribing authority, should not prescribe Viberzi in patients without a gallbladder.

Prescribers should consider over-the-counter alternatives (Pepto-Bismol, Kaopectate, Immodium, and Gas-x) or FDA approved medications (Lomotil, Lotronex or Xifaxan) to treat symptoms associated with IBS-D.

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