OVERVIEW

PRODUCT INFORMATION

CHEMICAL FORMULA AND STRUCTURE

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DRUG	CAS REGISTRY NUMBER	MOLECULAR FORMULA	STRUCTURE
Eluxadoline	864821-90-9	C32-H35-N5-O5

ANNOTATED BIBLIOGRAPHY

References updated: 20 April 2017

• Zimmerman HJ. Laxatives. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 721-3.

  (Expert review of hepatotoxicity published in 1999 before the availability of eluxadoline).
• Pasricha PJ. Treatment of disorders of bowel motility and water flux; antiemetics; agents used in biliary and pancreatic disease. In, Brunton LL, Lazo JS, Parker KL, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 11th ed. New York: McGraw-Hill, 2006, pp. 983-1008.

  (Textbook of pharmacology and therapeutics; eluxadoline not discussed).
• Shah E, Kim S, Chong K, Lembo A, Pimentel M. Evaluation of harm in the pharmacotherapy of irritable bowel syndrome. Am J Med 2012; 125: 381-93. [PubMed: 22444104]

  (Systematic review of adverse side effects of drugs used to treat irritable bowel syndrome, before the availability of eluxadoline).
• Lembo AJ, Lacy BE, Zuckerman MJ, Schey R, Dove LS, Andrae DA, Davenport JM, et al. Eluxadoline for irritable bowel syndrome with diarrhea. N Engl J Med 2016; 374: 242-53. [PubMed: 26789872]

  (Among 2427 adults with irritable bowel syndrome with diarrhea who were treated with eluxadoline [75 or 100 mg] or placebo twice daily for 26 or 52 weeks, symptoms improved with drug therapy and adverse events more frequent with eluxadoline included nausea [8% vs 5%], constipation [7% to 9% vs 2.5%] and abdominal pain [6% to 7% vs 4%], and 8 eluxadoline treated patients [0.3%], but no placebo recipient developed pancreatitis; severe adverse events were more frequent in patients with prior cholecystectomy [6.1-12.6% vs 2.7-3.7%], a difference also seen in placebo recipients [8.2% vs 1.7%]).
• Dove LS, Lembo A, Randall CW, Fogel R, Andrae D, Davenport JM, McIntyre G, et al. Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a phase 2 study. Gastroenterology 2013; 145: 329-38. [PubMed: 23583433]

  (Among 807 patients with irritable bowel disease with diarrhea treated with eluxadoline [5, 25, 100 or 200 mg] or placebo twice daily for 12 weeks, symptoms improved with the higher drug doses while overall adverse event rates were similar across groups, although 4 eluxadoline treated patients developed pancreatitis; nevertheless, "results from routine laboratory evaluations…were unremarkable”).
• Traynor K. Eluxadoline approved for irritable bowel syndrome with diarrhea. Am J Health Syst Pharm 2015; 72: 1078. [PubMed: 26092951]

  (News report on approval of eluxadoline for irritable bowel disease with diarrhea; mentions its association with occasional cases of pancreatitis).
• Eluxadoline (Viberzi) for irritable bowel syndrome with diarrhea. Med Lett Drugs Ther 2016; 58 (1485): 4-5. [PubMed: 26714241]

  (Concise review of the mechanism of action, clinical efficacy, safety and costs of eluxadoline therapy of irritable bowel disease with diarrhea; mentions adverse events of sphincter of Oddi spasm and pancreatitis in patients without a gallbladder or with preexisting hepato-biliary and pancreatic disease).
• Cash BD, Lacy BE, Schoenfeld PS, Dove LS, Covington PS. Safety of eluxadoline in patients with irritable bowel syndrome with diarrhea. Am J Gastroenterol 2017; 112: 365-74. [PMC free article: PMC5318664] [PubMed: 27922029]

  (Safety analysis of pooled data from 2814 patients in 3 placebo controlled clinical trials in irritable bowel syndrome, found side effects more frequent with eluxadoline than placebo to include constipation [7.4% to 8.1% vs 2.4%], nausea [7.1% to 8.1% vs 5%] and 10 episodes [0.6%] of severe abdominal pain suggestive of Sphincter of Oddi spasm usually accompanied by marked elevations in aminotransferase levels, all of which occurred in patients without a gallbladder).
• In brief: Pancreatitis with eluxadoline (Viberzi) in patients without a gallbladder. Med Lett Drugs Ther 2017; 59 (1519): 70. [PubMed: 28419076]

  (Brief review of an FDA communication on reports of 118 cases of serious pancreatitis and two fatal instances in patients without a gallbladder who received eluxadoline, stressing the contraindications to its use in patients with preexisting hepatobiliary and pancreatic disease).