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. 2019 Sep;85(9):2126-2133.
doi: 10.1111/bcp.14027. Epub 2019 Jul 31.

Adverse events reported for Mirena levonorgestrel-releasing intrauterine device in France and impact of media coverage

Claire Langlade  1   2 , Amandine Gouverneur  1   2 , Pauline Bosco-Lévy  1   3 , Aurore Gouraud  4 , Marie-Christine Pérault-Pochat  5 , Johana Béné  6 , Ghada Miremont-Salamé  1   2 , Antoine Pariente  1   2 ; French Network of Pharmacovigilance Centres
Affiliations

Adverse events reported for Mirena levonorgestrel-releasing intrauterine device in France and impact of media coverage

Claire Langlade et al. Br J Clin Pharmacol. 2019 Sep.

Abstract

Aims: In 2017, concerns regarding adverse events (AEs) associated with the Mirena levonorgestrel intrauterine device were largely echoed in the media in France. This resulted in a tremendous reporting of AEs to pharmacovigilance centres. 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 July 1995) until 04 August 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 May 2017).

Results: Overall, 3224 reports were considered, 510 (15.8%) recorded before the media coverage peak, and 2714 (84.2%) after. Before the peak, 76.5% of reports originated from health professionals; median time-to-report was of 5.5 months (interquartile range: 1.7-18.6), and median number of AEs per report was 1 (range: 1-17). After the peak, 98.6% originated from patients; median time-to-report was 21 months (interquartile range: 8.1-45.5), and median number of AEs per report was 6 (range: 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 emphasised 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.

Keywords: drug safety; gynaecology/obstetrics; pharmacovigilance.

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Conflict of interest statement

The study was conducted in the context of a national pharmacovigilance follow‐up for which the Centre de Pharmacovigilance de Bordeaux was appointed by the ANSM. The ANSM had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and the decision to submit the manuscript for publication. This publication represents the views of the authors and does not necessarily represent the opinion of the ANSM.

C.L., Am.G., P.B.‐L., Au.G, M.‐C.P.‐P., J.B., G.M., and A.P. have no competing interests to declare.

A.P. is the coordinator of the French DRUGS‐SAFE (DRUGS Systematized Assessment in real‐liFe Environment) national platform of pharmacoepidemiology. This national platform is granted by the ANSM. This work is not part of the DRUGS‐SAFE research programme (www.drugssafe.fr).

Figures

Figure 1
Figure 1
Reports to French network of pharmacovigilance Centres from 1 January 2017 to 4 August 2017.
See this image and copyright information in PMC

References

    1. Beatty MN, Blumenthal PD. The levonorgestrel‐releasing intrauterine system: safety, efficacy, and patient acceptability. Ther Clin Risk Manag. 2009;5:561‐574. - PMC - PubMed
    1. Santé publique France . [Les Françaises et la contraception: premières données du Baromètre santé 2016]. 2017. Available from: https://www.santepubliquefrance.fr/Actualites/Les‐Francaises‐et‐la‐contr.... Accessed December 20, 2018.
    1. [Méthode contraceptives: Focus sur les méthodes les plus efficaces disponibles]. Paris, France: Haute Autorité de Santé. Available from: https://www.has‐sante.fr/portail/upload/docs/application/pdf/2013‐03/syn.... Accessed December 20, 2018.
    1. Trussell J. Contraceptive failure in the United States. Contraception. 2011;83(5):397‐404. - PMC - PubMed
    1. Winner B, Peipert JF, Zhao Q, et al. Effectiveness of long‐acting reversible contraception. N Engl J Med. 2012;366(21):1998‐2007. - PubMed

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