Title

Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study

Authors

Richard L. Morrow, Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, 210-1110 Government St., Victoria, BC, V8W 1Y2, Canada. richard.morrow@ubc.ca.
Barbara Mintzes, Faculty of Medicine and Health and Charles Perkins Centre, School of Pharmacy, University of Sydney, Sydney, NSW, Australia.
Patrick C. Souverein, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Christine E. Hallgreen, Department of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark.
Bilal Ahmed, Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, 210-1110 Government St., Victoria, BC, V8W 1Y2, Canada.
Elizabeth E. Roughead, Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.
Marie L. De Bruin, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Sarah Brøgger Kristiansen, Department of Drug Design and Pharmacology, Pharmacovigilance Research Center, University of Copenhagen, Copenhagen, Denmark.
Joel Lexchin, Faculty of Health, York University, Toronto, ON, Canada.
Anna Kemp-Casey, Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.
Ingrid Sketris, Department of Community Health and Epidemiology, Dalhousie University, Halifax, NS, Canada.
Dee Mangin, Department of Family Medicine, McMaster University, Hamilton, ON, Canada.
Sallie-Anne Pearson, Faculty of Medicine, Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.
Lorri Puil, Faculty of Medicine, School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.
Ruth Lopert, Department of Health Policy and Management, George Washington University, Washington, DC, USA.
Lisa Bero, School of Medicine and Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Danijela Gnjidic, Faculty of Medicine and Health and Charles Perkins Centre, School of Pharmacy, University of Sydney, Sydney, NSW, Australia.
Ameet Sarpatwari, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Colin R. Dormuth, Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, 210-1110 Government St., Victoria, BC, V8W 1Y2, Canada.

Document Type

Journal Article

Publication Date

6-1-2022

Journal

Drug safety

Volume

45

Issue

6

DOI

10.1007/s40264-022-01175-2

Abstract

INTRODUCTION: Regulatory advisories on hydroxyzine and risk of QT prolongation and Torsade de pointes (TdP) were issued in the UK in April 2015 and Canada in June 2016. We hypothesized patients with risk factors for QT prolongation and TdP, compared with those without risk factors, would be less likely to initiate hydroxyzine in the UK and in British Columbia (BC), Canada, following advisories. METHODS: We conducted a longitudinal study with repeated measures, and evaluated hydroxyzine initiation in a UK cohort and a concurrent BC control cohort (April 2013-March 2016) as well as in a BC advisory cohort (June 2014-May 2017). RESULTS: This study included 247,665 patients in the UK cohort, 297,147 patients in the BC control cohort, and 303,653 patients in the BC advisory cohort. Over a 12-month post-advisory period, hydroxyzine initiation decreased by 21% in the UK (rate ratio 0.79, 95% confidence interval 0.66-0.96) relative to the expected level of initiation based on the pre-advisory trend. Hydroxyzine initiation did not change in the BC control cohort or following the Canadian advisory in the BC advisory cohort. The decrease in hydroxyzine initiation in the UK in the 12 months after the advisories was not significantly different for patients with risk factors compared with those without risk factors. CONCLUSION: Hydroxyzine initiation decreased in the UK, but not in BC, in the 12 months following safety advisories. The decrease in hydroxyzine initiation in the UK was not significantly different for patients with versus without risk factors for QT prolongation and TdP.

Department

Health Policy and Management

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