PMID- 31218710
OWN - NLM
STAT- MEDLINE
DCOM- 20200921
LR  - 20210109
IS  - 1365-2125 (Electronic)
IS  - 0306-5251 (Print)
IS  - 0306-5251 (Linking)
VI  - 85
IP  - 9
DP  - 2019 Sep
TI  - Adverse events reported for Mirena levonorgestrel-releasing intrauterine device 
      in France and impact of media coverage.
PG  - 2126-2133
LID - 10.1111/bcp.14027 [doi]
AB  - 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.
CI  - (c) 2019 The British Pharmacological Society.
FAU - Langlade, Claire
AU  - Langlade C
AD  - Univ. Bordeaux, Inserm, Bordeaux Population Health Research Centre, team 
      PHARMACOEPIDEMIOLOGY, UMR 1219, Bordeaux, France.
AD  - Pole de sante publique, Service de Pharmacologie Medicale, Centre Regional de 
      Pharmacovigilance de Bordeaux, CHU de Bordeaux, Bordeaux, France.
FAU - Gouverneur, Amandine
AU  - Gouverneur A
AUID- ORCID: 0000-0001-6253-1833
AD  - Univ. Bordeaux, Inserm, Bordeaux Population Health Research Centre, team 
      PHARMACOEPIDEMIOLOGY, UMR 1219, Bordeaux, France.
AD  - Pole de sante publique, Service de Pharmacologie Medicale, Centre Regional de 
      Pharmacovigilance de Bordeaux, CHU de Bordeaux, Bordeaux, France.
FAU - Bosco-Levy, Pauline
AU  - Bosco-Levy P
AD  - Univ. Bordeaux, Inserm, Bordeaux Population Health Research Centre, team 
      PHARMACOEPIDEMIOLOGY, UMR 1219, Bordeaux, France.
AD  - INSERM CIC1401, Bordeaux PharmacoEpi, Bordeaux, France.
FAU - Gouraud, Aurore
AU  - Gouraud A
AD  - Service Hospitalo-Universitaire de Pharmacotoxicologie, CHU de Lyon, Lyon, 
      France.
FAU - Perault-Pochat, Marie-Christine
AU  - Perault-Pochat MC
AD  - Pharmacologie clinique et vigilances, LNEC, INSERM U1084, CHU de Poitiers, 
      Poitiers, France.
FAU - Bene, Johana
AU  - Bene J
AD  - Centre de pharmacovigilance du Nord Pas de Calais, 1 place de Verdun, Lille, 
      France.
FAU - Miremont-Salame, Ghada
AU  - Miremont-Salame G
AD  - Univ. Bordeaux, Inserm, Bordeaux Population Health Research Centre, team 
      PHARMACOEPIDEMIOLOGY, UMR 1219, Bordeaux, France.
AD  - Pole de sante publique, Service de Pharmacologie Medicale, Centre Regional de 
      Pharmacovigilance de Bordeaux, CHU de Bordeaux, Bordeaux, France.
FAU - Pariente, Antoine
AU  - Pariente A
AD  - Univ. Bordeaux, Inserm, Bordeaux Population Health Research Centre, team 
      PHARMACOEPIDEMIOLOGY, UMR 1219, Bordeaux, France.
AD  - Pole de sante publique, Service de Pharmacologie Medicale, Centre Regional de 
      Pharmacovigilance de Bordeaux, CHU de Bordeaux, Bordeaux, France.
CN  - French Network of Pharmacovigilance Centres
LA  - eng
PT  - Journal Article
DEP - 20190731
PL  - England
TA  - Br J Clin Pharmacol
JT  - British journal of clinical pharmacology
JID - 7503323
RN  - 5W7SIA7YZW (Levonorgestrel)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Anxiety/chemically induced/epidemiology
MH  - Depression/chemically induced/epidemiology
MH  - Female
MH  - France/epidemiology
MH  - Hospitalization/statistics & numerical data
MH  - Humans
MH  - *Information Dissemination
MH  - Intrauterine Devices/*adverse effects
MH  - Levonorgestrel/administration & dosage/*adverse effects
MH  - Male
MH  - Mass Media/*statistics & numerical data
MH  - Pharmacovigilance
MH  - Sexual Dysfunction, Physiological/chemically induced/epidemiology
PMC - PMC6710510
OTO - NOTNLM
OT  - drug safety
OT  - gynaecology/obstetrics
OT  - pharmacovigilance
COIS- 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).
EDAT- 2019/06/21 06:00
MHDA- 2020/09/22 06:00
PMCR- 2020/09/01
CRDT- 2019/06/21 06:00
PHST- 2018/12/20 00:00 [received]
PHST- 2019/04/30 00:00 [revised]
PHST- 2019/05/15 00:00 [accepted]
PHST- 2019/06/21 06:00 [pubmed]
PHST- 2020/09/22 06:00 [medline]
PHST- 2019/06/21 06:00 [entrez]
PHST- 2020/09/01 00:00 [pmc-release]
AID - BCP14027 [pii]
AID - 10.1111/bcp.14027 [doi]
PST - ppublish
SO  - Br J Clin Pharmacol. 2019 Sep;85(9):2126-2133. doi: 10.1111/bcp.14027. Epub 2019 
      Jul 31.