Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study
Richard L. Morrow (),
Barbara Mintzes,
Patrick C. Souverein,
Christine E. Hallgreen,
Bilal Ahmed,
Elizabeth E. Roughead,
Marie L. Bruin,
Sarah Brøgger Kristiansen,
Joel Lexchin,
Anna Kemp-Casey,
Ingrid Sketris,
Dee Mangin,
Sallie-Anne Pearson,
Lorri Puil,
Ruth Lopert,
Lisa Bero,
Danijela Gnjidic,
Ameet Sarpatwari and
Colin R. Dormuth
Additional contact information
Richard L. Morrow: University of British Columbia
Barbara Mintzes: University of Sydney
Patrick C. Souverein: Utrecht University
Christine E. Hallgreen: University of Copenhagen
Bilal Ahmed: University of British Columbia
Elizabeth E. Roughead: University of South Australia
Marie L. Bruin: Utrecht University
Sarah Brøgger Kristiansen: University of Copenhagen
Joel Lexchin: York University
Anna Kemp-Casey: University of South Australia
Ingrid Sketris: Dalhousie University
Dee Mangin: McMaster University
Sallie-Anne Pearson: University of New South Wales
Lorri Puil: University of British Columbia
Ruth Lopert: George Washington University
Lisa Bero: University of Colorado Anschutz Medical Campus
Danijela Gnjidic: University of Sydney
Ameet Sarpatwari: Brigham and Women’s Hospital and Harvard Medical School
Colin R. Dormuth: University of British Columbia
Drug Safety, 2022, vol. 45, issue 6, No 3, 623-638
Abstract:
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.
Date: 2022
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DOI: 10.1007/s40264-022-01175-2
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