ArticleBritish journal of clinical pharmacology2019
Adverse events reported for Mirena levonorgestrel-releasing intrauterine device in France and impact of media coverage.
Article in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed, 19 citations in OpenAlex.
- Endometriosis as a Systemic and Complex Disease: Toward Phenotype-Based Classification and Personalized Therapy.International journal of molecular sciences · 2026Review
- Comparative Analysis of Drugs Frequently Suspected of Causing Adverse Drug Reactions Reported via the Spontaneous Reporting System Versus in a Prospective Multicentre Cohort Study in Hospital Emergency Departments.Journal of clinical medicine · 2025Article
- Pharmacovigilance study of the association between progestogen and depression based on the FDA adverse event reporting System (FAERS).Scientific reports · 2025Article
- Review
- Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France.Drug safety · 2023Article
- Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France.European journal of clinical pharmacology · 2023Article
- Patient reporting of sexual adverse events on an online platform for medication experiences.British journal of clinical pharmacology · 2022Article
- Human Papillomavirus Vaccination and Premature Ovarian Failure: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System.Drugs - real world outcomes · 2022Article
- Adverse events reported for Mirena levonorgestrel-releasing intrauterine device in France and impact of media coverage.British journal of clinical pharmacology · 2019Article
Corrections and comments
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Authors and funding
9 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsIn 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.
methodsAll 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).
resultsOverall, 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%).
conclusionThis 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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