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Master Thesis

Dispositif intra-utérin au lévonorgestrel Mirena® : effets indésirables rapportés et impact de la médiatisation sur la notification spontanée en France

Abstract : Introduction: In 2017, concerns regarding Adverse Events (AEs) associated with levonorgestrel Intra-Uterine Device Mirena® were largely echoed in medias in France. This resulted in a tremendous reporting of AEs to Pharmacovigilance Centres. Objectives: The aim of this study was to describe the reporting of AEs regarding Mirena® in France and to study the impact of media coverage on this reporting. Methods: All cases reports involving Mirena® recorded in the French national pharmacovigilance database from marketing (21/07/1995) until 04/08/2017 were extracted. To allow studying the influence of mediatisation, reports were described separately for the periods preceding and following the observed media coverage peak (15/05/2017). Results: Overall, 3,224 reports were considered, 510 (15.8%) recorded before the media coverage peak, and 2,714 (84.2%) after. Before the peak, 76.5% of reports originated from health professionals; median time-to-report was of 5.5 months (IQR: 1.7-18.6), and median number of AEs per report of 1 (min-max: 1-17). After the peak, 98.6% originated from patients; median time-to-report was 21 months (IQR: 8.1-45.5), and median number of AEs per report was 6 (min-max: 1-37). After the peak, most reports mentioned anxio-depressive disorders (38.8% vs 10.6% before) or sexual disorders (47.3% vs 6.9%). Other emphasized AEs were weight increase (42.3% vs 10.2%) and pain (gastrointestinal, 19.1% vs 3.5%; musculoskeletal, 22.2% vs 4.5%). Conclusion: This study highlighted the importance of mediatisation impact on spontaneous reporting with changes concerning amounts of reports, type of reporter, and type of reported AEs. For Mirena®, this led to generate signals regarding anxio-depressive and sexual disorders.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-02302382
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Submitted on : Tuesday, October 1, 2019 - 2:35:24 PM
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Claire Langlade. Dispositif intra-utérin au lévonorgestrel Mirena® : effets indésirables rapportés et impact de la médiatisation sur la notification spontanée en France. Sciences du Vivant [q-bio]. 2019. ⟨dumas-02302382⟩

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