The incidence of torsades de pointes with peri-operative low-dose ondansetron administration.

Abstract

STUDY OBJECTIVE:

The primary objective of this retrospective safety study was to determine the incidence of torsades de pointes (TdP) or death following perioperative administration of low-dose, 4 mg, ondansetron for postoperative nausea and vomiting.

DESIGN AND SETTING:

This is a single-center retrospective clinical trial.

PATIENTS:

The authors identified 32,737 patients who received 37,589 doses of ondansetron during a 2-year time frame between March 2009 and February 2011 for surgical nausea prophylaxis or treatment of nausea.

MEASUREMENTS AND MAIN RESULTS:

Patients were cross-matched with an electrocardiogram and adverse outcome database; this identified 4759 patients with documentation of a QTc >450 milliseconds (ms), all ventricular tachycardias including TdP within 48 hours of receiving ondansetron, or death within 7 days of receiving ondansetron. No patients developed TdP or died as a direct result of ondansetron administration (n = 0; event rate = 0.0 per 10,000, 95% CI 0.0 to 1.1 per 10,000). Forty-six of 32,737 surgical patients had documented monomorphic ventricular tachycardia (VT) (n = 14; event rate = 4.3 per 10,000, 95% CI 2.3 to 7.2 per 10,000) or died (n = 32; event rate = 9.8 per 10,000, 95% CI 6.7 to 13.8 per 10,000) within 48 h of ondansetron administration. All monomorphic VT episodes were precipitated by existing cardiovascular disease; and 7 of 14 patients had documented monomorphic VT prior to receiving ondansetron. Of the 32 surgical patients who died, all deaths were precipitated by pre-existing disease.

CONCLUSION:

No episodes of TdP were identified in patients receiving ondansetron perioperatively. This suggests that low-dose ondansetron does not contribute to the development of TdP.

• Authors: Gregory A Nuttall, Sarah C Voogd, Heather Danke, Paul A Warner, Lance J Oyen, Mary Shirk Marienau, Michael J Ackerman
• Journal: Pharmacotherapy (Pharmacotherapy) Vol. 42 Issue 4 Pg. 292-297 (04 2022) ISSN: 1875-9114 [Electronic] United States
• PMID: 35124842 (Publication Type: Clinical Trial, Journal Article)
• Copyright: © 2022 Pharmacotherapy Publications, Inc.

Chemical References

• Antiemetics
• DNA-Binding Proteins
• Ondansetron

Topics

• Antiemetics (adverse effects)
• DNA-Binding Proteins
• Humans
• Incidence
• Ondansetron (adverse effects)
• Postoperative Nausea and Vomiting (epidemiology)
• Retrospective Studies
• Tachycardia, Ventricular (chemically induced, drug therapy, epidemiology)
• Torsades de Pointes (chemically induced, epidemiology)
• Vomiting (chemically induced)