0 avis
Adverse events reported for Mirena levonorgestrel-releasing intrauterine device in France and impact of media coverage. : Br J Clin Pharmacol
Archive ouverte
International audience. INTRODUCTION: In 2017, concerns regarding Adverse Events (AEs) associated with levonorgestrel Intra-Uterine Device Mirena(R) 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(R) in France and to study the impact of media coverage on this reporting. METHODS: All cases reports involving Mirena(R) 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(R), this led to generate signals regarding anxio-depressive and sexual disorders.
Consulter en ligne
Suggestions
Du même auteur
