FDA Warns Against Using Viberzi in Patients without a Gallbladder
Allergan’s Viberzi (eluxadoline), a drug used to treat irritable bowel syndrome with diarrhea, can increase the risk of pancreatitis in patients without a gallbladder. According to the U.S. Food and Drug Administration (FDA), this could lead to hospitalization or death. As such, the agency is warning against using Viberzi in patients who do not have a gallbladder.
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Regulators released a Drug Safety Communication on Mar. 15 warning against the use of Viberzi in patients without a gallbladder. The agency says that the pancreatitis, or inflammation of the pancreas, may result from the spasm of a muscle in the small intestine. The FDA says it is working with Allergan to address the risk of pancreatitis associated with Viberzi.
Viberzi is used to treat adults suffering from irritable bowel syndrome with diarrhea, a condition affecting the large intestine. Patients with this condition may experience cramping, pain the stomach or abdominal area, bloating, gas, and diarrhea. Viberzi aims to alleviate these symptoms by reducing bowel contractions. The drug can lessen diarrhea, reduce pain in the stomach and abdomen, and improve stool consistency.
According to the Drug Safety Communication, regulators conducted a review and found that patients without a gallbladder can develop serious pancreatitis when taking Viberzi. The agency says it received 120 reports of serious cases of pancreatitis or death through the FDA Adverse Event Reporting System between May 2015 and February 2017. Among these patients, 68 reported their gallbladder status. A total of 56 patients reported not having a gallbladder, and received the currently recommended dosage of Viberzi.
The FDA says 76 patients were hospitalized for pancreatitis after taking Viberzi, including two patients who died. The patients who died did not have a gallbladder. Regulators state that in some reports of serious pancreatitis or death, patients also experienced sphincter of Oddi spasm or abdominal pain. These adverse events were reported in 6 and 16 patients, respectively.
According to the FDA alert, one patient died from pancreatitis. This patient suffered from acute, severe abdominal pain, nausea and vomiting within one hour of taking a single dose of Viberzi. The FDA says this patient died within three days of taking the first dose of the medication. The other death associated with Viberzi was caused by a sphincter of Oddi spasm, which leads to abdominal pain and vomiting shortly after taking the first dose. Both patients were hospitalized for their symptoms.
FDA Recommendations for Patients and Health Care Professionals
The FDA advises patients to contact their health care professional about controlling symptoms of irritable bowel syndrome with diarrhea. This recommendation applies particularly to patients without a gallbladder, the organ primarily responsible for storing bile. Bile is a digestive juice that helps break down fat. Patients experiencing new or worsening stomach-area or abdomen pain, pain the upper right side of the stomach area, or abdomen pain that can move to the back or shoulder should stop taking Viberzi immediately and seek emergency medical care, the agency said. Patients experiencing pain may also suffer from nausea and vomiting. These symptoms can be indicative of pancreatitis or spasm of the sphincter of Oddi, a muscular valve in the small intestine.
Regulators are advising health care professionals against prescribing Viberzi in patients without a gallbladder. An alternative treatment option should be considered for treating irritable bowel syndrome with diarrhea in these patients, the FDA says. The agency notes that “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.”
There are both prescription and over-the-counter alternatives available to treat patients suffering from irritable bowel syndrome with diarrhea, the FDA said. The agency says alternative treatment options for diarrhea include OTC bismuth subsalicylate (Kaopectate and Pepto-Bismol), OTC loperamide (Imodium), and prescription medicine diphenoxylate/ atropine (Lomotil). The FDA has approved the drugs alosetron hydrochloride (Lotronex) and the antibiotic rifaximin (Xifaxan) for irritable bowel syndrome with diarrhea.
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