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FDA Warns Some Patients to Avoid Viberzi

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Individuals who have irritable bowel syndrome (IBS) typically suffer from symptoms like abdominal pain, cramping, bloating, and diarrhea or constipation. Viberzi (eluxadoline), a prescription drug manufactured by Allergan, was approved in 2015 to treat IBS and help people manage their symptoms.

Recently, however, the FDA warned that Viberzi can increase the risk of serious pancreatitis, an inflammation of the pancreas that can lead to hospitalization and even death.

FDA Warns that Viberzi Linked to Pancreatitis

In March 2017, the FDA released a new safety communication warning patients and doctors about the risk. According to the FDA, between May 2015, when Viberzi was first approved, and February 2017, it received 120 reports of serious cases of pancreatitis or death. Seventy-six of the 120 patients were hospitalized, and two of them died. The two deceased patients did not have a gallbladder following gallbladder removal surgery. The FDA urged health care professionals not to use Viberzi in patients without a gallbladder.

How Viberzi May Affect the Pancreas

Why would a gallbladder make such a difference when taking Viberzi? By activating opioid receptors in the gut, the drug decreases contractions of the bowel, relaxing it so it doesn’t cause diarrhea, while easing abdominal pain.

Viberzi may cause problems in two ways:

  1. by directly affecting the pancreas; and
  2. by affecting the sphincter of Oddi, and indirectly affecting the pancreas

The pancreas is a gland in the abdomen that is part of the digestive system. It produces insulin, enzymes, and hormones, and then releases these through fluids that help break down foods. The sphincter of Oddi is a round valve that helps control the opening into the small intestine. Both bile and pancreatic juices flow through this valve into the small intestine. In rare cases, this valve can spasm, where it clamps shut and cannot relax open again.

If this happens, digestive juices, including bile and those released by the pancreas, can begin to back up into the gallbladder, the pancreas, and the bile ducts of the liver. In people without a gallbladder, the fluids go directly to the pancreas, where digestive enzymes can cause inflammation.

Viberzi works to slow and stop muscle contractions. It’s meant to work on the bowel, but it may also affect the sphincter of Oddi, causing it to clamp down. This is a serious condition that typically requires medication or even complicated surgery.

Allergan Failed to Warn Patients Without a Gallbladder

The original Viberzi label cautioned that people without a gallbladder should use a reduced dose.  But now the FDA has advised that people without a gallbladder should not use Viberzi at all. Patients who were unaware of this risk and suffered from pancreatitis, as a result, may be eligible to file a Viberzi lawsuit in an effort to recover damages.

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