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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].

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Serotonin 5-HT3 Receptor Antagonists

Last Update: January 15, 2018.

OVERVIEW

Introduction

The serotonin type 3 (5-HT3) receptor antagonists are potent antiemetics used for prevention of postsurgical or chemotherapy induced nausea and vomiting and for some agents as therapy of diarrhea-predominant irritable bowel syndrome. The 5-HT3 receptor antagonists are associated with a low rate of transient serum enzyme elevations during therapy, but have been only rarely implicated in cases of clinically apparent liver injury.

Background

The 5-HT3 receptor antagonists act to block the effects of serotonin on specific receptors that are found most frequently in the gastrointestinal tract and the central nervous system. The antiemetic effects appear to be the result of both central and peripheral inhibition of serotonin activity, with a decrease in vagal activity as well as interruption of pathways in the chemoreceptor trigger zone and solitary tract nucleus of the brainstem. 5-HT3 receptor antagonists in clinical use for treatment of nausea and vomiting in the United States include (with brand name and year of approval) granisetron (Kytril: 1994), dolasetron (Anzemet: 1997), ondansetron (Zofran: 1999), and palonosetron (Aloxi: 2003). All except palonosetron are also available in generic forms. These four 5-HT3 receptor antagonists are approved for prevention of nausea and vomiting after major surgery, chemotherapy or radiation therapy. They are sometimes used off-label to treat severe nausea and vomiting including that from hyperemesis gravidarum and acute gastroenteritis. They are not effective for motion sickness. These agents are generally given intravenously before or at the time of chemotherapy or surgery, but are also available as oral tablets, capsules and solutions, but are usually given for 1 to 3 days only. Common side effects include headache, fatigue, dizziness and constipation.

Alosetron (al oh’ se tron) is a 5-HT3 receptor blocker, but was developed and used largely for management of diarrhea-predominant irritable bowel syndrome rather than as an antiemetic. Its introduction in the 1990s however, was followed by cases of severe, even life-threatening, constipation which led to its withdrawal in 2000. Alosetron was reintroduced in 2002 with restrictions on its availability and limitation to women with severe diarrhea-predominant irritable bowel syndrome. Alosetron is available as 0.5 and 1.0 mg tablets generically and under the brand name Lotronex. The typical initial dose in adults is 0.5 mg twice daily, which can be increased to 1 mg twice daily if it is well tolerated. Side effects include abdominal pain and constipation, which can be severe resulting in intestinal obstruction, ileus, impaction and ischemic colitis. Patients treated with alosetron must be enrolled in a prescribing program and have regular monitoring for side effects.

Dolasetron (doe las’ e tron) is a 5-HT3 receptor blocker used as an antiemetic to prevent nausea and vomiting postoperatively or after cancer chemotherapy. It was first approved in 1997 and is available as tablets of 50 and 100 mg and as a solution for injection in single or multidose vials (20 mg/mL) under the brand name Anzemet. As with most 5-HT3 receptor blockers, the dose varies by mode of administration, indication and expected severity and duration of nausea. Side effects include headache, fatigue, diarrhea and dizziness. Dolasetron can prolong the QTc interval and is susceptible to drug-drug interactions.

Granisetron (gra nis’ e tron) is a 5-HT3 receptor blocker used as an antiemetic to prevent nausea and vomiting postoperatively or after cancer chemotherapy. Introduced in 1993, granisetron is available as tablets of 1 mg and as a solution for injection in single or multidose vials (1 mg/mL) generically and under the brand name Kytril. A transdermal patch of granisetron for prevention of chemotherapy associated nausea and vomiting is also available (Sancuso). As with other 5-HT3 receptor blockers, the dose varies by mode of administration, indication and expected severity and duration of nausea. Side effects of granisetron can include headache, fatigue, diarrhea and dizziness.

Ondansetron (on dan’ se tron) is a 5-HT3 receptor blocker that was developed as an antiemetic and was introduced in 1993, the first of this class of anti-emetic agents. The current indications are for prevention of nausea and vomiting postoperatively or after cancer chemotherapy. Ondansetron is available as tablets of 4, 8, 16 and 24 mg and as a solution for injection in single or multidose vials (2 mg/mL) in multiple generic forms and under the brand name Zofran. As with other 5-HT3 receptor blockers, the dose varies by mode of administration, indication and expected severity and duration of nausea. Side effects include headache, fatigue, diarrhea and dizziness. Ondansetron can prolong the QTc interval.

Palonosetron (pal” oh noe’ se tron) is a 5-HT3 receptor blocker that was developed as an antiemetic and introduced in 2003. The current indications are prevention of nausea and vomiting postoperatively or after cancer chemotherapy. Palonosetron is available as capsules of 0.5 mg and as a solution for injection in single or multidose vials (0.05 mg/mL) generically and under the brand name Aloxi. As with other 5-HT3 receptor blockers, the dose varies by mode of administration, indication and expected severity and duration of nausea. Side effects include headache, fatigue, diarrhea and dizziness. Palonosetron has not been shown to prolong the QTc interval.

Hepatotoxicity

The 5-HT3 receptor antagonists have been linked to occasional instances of serum enzyme elevations during therapy, but these are generally mild and asymptomatic, resolving rapidly. Because they are used at the time of surgery and with chemotherapy, instances of liver injury arising after their use have been reported, but other drugs or factors may have played a role in the published cases. The rate of serum enzyme elevations with 5-HT3 receptor antagonist therapy has ranged from 1% to 8% and has generally been no greater than that observed with placebo therapy. While moderate serum enzyme elevations during 5-HT3 receptor antagonist therapy have been described, there have been have been only rare and isolated reports of clinically apparent acute liver injury with jaundice attributed to these agents. The onset of injury has been within 1 to 2 weeks of exposure and the pattern of injury hepatocellular and without immunoallergic or autoimmune features. Instances of recurrence after re-exposure have been published. No instances of acute liver failure, chronic hepatitis or vanishing bile duct syndrome have been attributed to the 5-HT3 receptor antagonists.

Alosetron likelihood score: D (possible cause of clinically apparent liver injury).

Dolasetron likelihood score: E (unlikely cause of clinically apparent liver injury).

Granisetron likelihood score: E (unlikely cause of clinically apparent liver injury).

Ondansetron likelihood score: D (possible cause of clinically apparent liver injury).

Palonosetron likelihood score: E (unlikely cause of clinically apparent liver injury).

Mechanism of Injury

The 5-HT3 receptor blockers are metabolized in the liver, largely via the cytochrome P450 system, but appear to have a low potential for causing liver injury. All except alosetron are used in low doses for short periods of time which may account for their relative lack of hepatotoxicity.

Outcome and Management

Serum aminotransferase elevations above 5 times the upper limit of normal (if confirmed) should lead to dose reduction or temporary cessation. Clinically apparent liver injury due to the 5-HT3 receptor blockers is rare, generally mild and self-limited and frequently arises only after the agent is discontinued. Rechallenge with the same agent can lead to reoccurrence but in some instances patients have tolerated other 5-HT3 receptor blockers without reappearance of liver injury.

Drug Class: Gastrointestinal Agents, Antiemetics

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Alosetron – Generic, Lotronex®

Dolasetron – Generic, Anzemet®

Granisetron – Generic, Kytril®

Ondansetron – Generic, Zofran®

Palonosetron – Aloxi®

DRUG CLASS

Gastrointestinal Agents

COMPLETE LABELING

Product labeling at DailyMed, National Library of Medicine, NIH

CHEMICAL FORMULAS AND STRUCTURES

DRUGCAS REGISTRY NO.MOLECULAR FORMULASTRUCTURE
Alosetron 122852-42-0 C17-H18-N4-O
Alosetron Chemical Structure
Dolasetron 115956-12-2 C19-H20-N2-O3
Dolasetron Chemical Structure
Granisetron 109889-09-0 C18-H24-N4-O
Granisetron Chemical Structure
Ondansetron 99614-02-5 C18-H19-N3-O
Ondansetron Chemical Structure
Palonosetron 135729-61-2 C19-H24-N2-O
Palonosetron Chemical Structure

ANNOTATED BIBLIOGRAPHY

References updated: 15 January 2018

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    (Review of the literature on the safety and efficacy of the 5-HT3 receptor blockers used as antiemetics, discusses symptoms of headache, dizziness, constipation and diarrhea, but not ALT or other laboratory abnormalities; no mention of hepatotoxicity).
  • Park H, Oh K, Lee H, Lee JH, Kang SM, Park SY, Kwon HS, Cho YS, Moon HB, Kim TB. Palonosetron-induced anaphylaxis during general anesthesia: A case report. Allergy Asthma Immunol Res 2017; 9: 92-5. [PMC free article: PMC5102841] [PubMed: 27826967]
    (37 year old man developed hypotension immediately after an infusion of palonosetron during surgery with subsequent rash and facial edema, responding to corticosteroid therapy; no mention of ALT elevations or hepatotoxicity).
  • Kovács G, Wachtel A, Basharova E, Spinelli T, Nicolas P, Kabickova E. Palonosetron compared with ondansetron in pediatric cancer patients: multicycle analysis of a randomized Phase III study. Future Oncol 2017; 13: 1685-98. [PubMed: 28569078]
    (Among 502 children receiving up to 4 cycles of cancer chemotherapy who were treated with one of two doses of palonosetron or ondansetron, higher doses of palonosetron were associated with fewer emetic episodes while adverse event rates were similar; no mention of ALT elevations or hepatotoxicity).
  • Takahashi T, Okada T, Ikejiri F, Ito S, Okada Y, Takahashi F, Kumanomido S, et al. A prospective study of palonosetron for prevention of chemotherapy-induced nausea and vomiting in malignant lymphoma patients following highly emetogenic chemotherapy. Int J Clin Oncol 2017 Aug 19. [PubMed: 28823027]
    (Among 59 patients with lymphoma treated with palonosetron, 94% had no nausea or vomiting and adverse events were mild including ALT elevations in 6 [12%], all of which were less than 5 times ULN).

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