Stephen B Freedman1, Elizabeth Uleryk2, Maggie Rumantir3, Yaron Finkelstein4. 1. Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada. 2. Hospital Library and Archives, The Hospital for Sick Children, Toronto, Ontario, Canada; Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada. 3. Hospital for Sick Children Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada. 4. Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada; Hospital for Sick Children Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada; Divisions of Paediatric Emergency Medicine and Clinical Pharmacology and Toxicology, Department of Paediatrics, The Hospital for Sick Children, Toronto, Ontario, Canada; Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada. Electronic address: yaron.finkelstein@sickkids.ca.
Abstract
STUDY OBJECTIVE: To explore the risk of cardiac arrhythmias associated with ondansetron administration in the context of recent recommendations for identification of high-risk individuals. METHODS: We conducted a postmarketing analysis and systematically reviewed the published literature, grey literature, manufacturer's database, Food and Drug Administration Adverse Events Reporting System, and the World Health Organization Individual Safety Case Reports Database (VigiBase). Eligible cases described a documented (or perceived) arrhythmia within 24 hours of ondansetron administration. The primary outcome was arrhythmia occurrence temporally associated with the administration of a single, oral ondansetron dose. Secondary objectives included identifying all cases associating ondansetron administration (any dose, frequency, or route) to an arrhythmia. RESULTS: Primary: No reports describing an arrhythmia associated with single oral ondansetron dose administration were identified. Secondary: Sixty unique reports were identified. Route of administration was predominantly intravenous (80%). A significant medical history (67%) or concomitant use of a QT-prolonging medication (67%) was identified in 83% of reports. Approximately one third occurred in patients receiving chemotherapeutic agents, many of which are known to prolong the QT interval. An additional third involved administration to prevent postoperative vomiting. CONCLUSION: Current evidence does not support routine ECG and electrolyte screening before single oral ondansetron dose administration to individuals without known risk factors. Screening should be targeted to high-risk patients and those receiving ondansetron intravenously.
STUDY OBJECTIVE: To explore the risk of cardiac arrhythmias associated with ondansetron administration in the context of recent recommendations for identification of high-risk individuals. METHODS: We conducted a postmarketing analysis and systematically reviewed the published literature, grey literature, manufacturer's database, Food and Drug Administration Adverse Events Reporting System, and the World Health Organization Individual Safety Case Reports Database (VigiBase). Eligible cases described a documented (or perceived) arrhythmia within 24 hours of ondansetron administration. The primary outcome was arrhythmia occurrence temporally associated with the administration of a single, oral ondansetron dose. Secondary objectives included identifying all cases associating ondansetron administration (any dose, frequency, or route) to an arrhythmia. RESULTS: Primary: No reports describing an arrhythmia associated with single oral ondansetron dose administration were identified. Secondary: Sixty unique reports were identified. Route of administration was predominantly intravenous (80%). A significant medical history (67%) or concomitant use of a QT-prolonging medication (67%) was identified in 83% of reports. Approximately one third occurred in patients receiving chemotherapeutic agents, many of which are known to prolong the QT interval. An additional third involved administration to prevent postoperative vomiting. CONCLUSION: Current evidence does not support routine ECG and electrolyte screening before single oral ondansetron dose administration to individuals without known risk factors. Screening should be targeted to high-risk patients and those receiving ondansetron intravenously.
Authors: Mildren A Del-Sueldo; María A Mendonça-Rivera; Martha B Sánchez-Zambrano; Judith Zilberman; Ana G Múnera-Echeverri; María Paniagua; Lourdes Campos-Alcántara; Claudia Almonte; Amalia Paix-Gonzales; Claudia V Anchique-Santos; Claudine J Coronel; Gabriela Castillo; María G Parra-Machuca; Ivanna Duro; Paola Varletta; Patricia Delgado; Verónica I Volberg; Adriana C Puente-Barragán; Adriana Rodríguez; Aida Rotta-Rotta; Anabela Fernández; Ana C Izeta-Gutiérrez; Ana E Ancona-Vadillo; Analía Aquieri; Andrea Corrales; Andrea Simeone; Bibiana Rubilar; Carolina Artucio; Carolina Pimentel-Fernández; Celi Marques-Santos; Clara Saldarriaga; Christian Chávez; Cristina Cáceres; Dahiana Ibarrola; Daniela Barranco; Edison Muñoz-Ortiz; Edith D Ruiz-Gastelum; Eduardo Bianco; Elena Murguía; Enrique Soto; Fabiola Rodríguez-Caballero; Fanny Otiniano-Costa; Giovanna Valentino; Iris B Rodríguez-Cermeño; Ivan R Rivera; Jairo A Gándara-Ricardo; Jesús A Velásquez-Penagos; Judith Torales; Karina Scavenius; Karen Dueñas-Criado; Laura García; Laura Roballo; Lucía R Kazelian; Macarena Coussirat-Liendo; María C Costa-Almeida; Mariana Drever; Mariela Lujambio; Marildes L Castro; Maritza Rodríguez-Sifuentes; Mónica Acevedo; Mónica Giambruno; Mónica Ramírez; Nancy Gómez; Narcisa Gutiérrez-Castillo; Onelia Greatty; Paola Harwicz; Patricia Notaro; Rocío Falcón; Rosario López; Sady Montefilpo; Sara Ramírez-Flores; Silvina Verdugo; Soledad Murguía; Sonia Constantini; Thais C Vieira; Virginia Michelis; César M Serra Journal: Arch Cardiol Mex Date: 2022
Authors: Stephen B Freedman; Dion Pasichnyk; Karen J L Black; Eleanor Fitzpatrick; Serge Gouin; Andrea Milne; Lisa Hartling Journal: PLoS One Date: 2015-06-15 Impact factor: 3.240