Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice

Slattery, Jim; Moralès, Daniel; Kurz, Xavier

doi:10.1007/s40264-018-0683-x

Cited by 25 publications

(15 citation statements)

References 11 publications

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“…As previously reported, we found a weak association of LNG exposure with anxiety. This finding is in line with results of an UK cohort study of new IUDs users (HR: 1.18, 95%CI 1.08; 1.29, [21]). Our study used however a more robust statistical method.…”

Section: Discussionsupporting

confidence: 90%

Safety of levonorgestrel 52 mg intrauterine system compared to copper intrauterine device: a population-based cohort study

et al. 2019

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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 French Medicines Agency (Agence Nationale de Sécurité des Médicaments, 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.

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Section: Discussionsupporting

confidence: 90%

Safety of levonorgestrel 52 mg intrauterine system compared to copper intrauterine device: a population-based cohort study

et al. 2019

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“…Almost all these events are described in the SPC. Moreover, the anxio‐depressive safety signal was found in a population‐based cohort study of the safety of the Mirena levonorgestrel IUD compared to copper IUDs and with another recent observational study …”

Section: Discussionmentioning

confidence: 67%

“…Moreover, the anxio-depressive safety signal was found in a population-based cohort study of the safety of the Mirena levonorgestrel IUD compared to copper IUDs and with another recent observational study. 20,21 The media coverage peak highlighted and broadcasted information about AEs of Mirena, informing the users that their symptoms could be related to potential AEs of their levonorgestrel-releasing IUD they were unaware of. Indeed, many consumers reported long-standing symptoms, such as depression, weight gain, abdominal pain or breast tenderness, which they had not attributed previously to their levonorgestrel-releasing IUD.…”

Section: Discussionmentioning

confidence: 99%

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

Langlade

Gouverneur

Bosco‐Lévy

et al. 2019

Brit J Clinical Pharma

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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.

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“…In accordance with these findings, a recent Danish national register study reviewed the records of over one million women and observed that the use of LNG-IUS was associated with subsequent antidepressant use and first diagnosis of depression (4). In addition, a cohort study investigating psychiatric ADRs associated with LNG-IUS in the UK general practice, found significant associations between levonorgestrel exposure and records of anxiety and sleep disturbances (6).…”

Section: Discussionmentioning

confidence: 84%

“…Due to the localized release of the drug, blood serum levels of levonorgestrel are lower compared to other hormonal contraceptives, and ADRs were supposed to occur less pronounced or mainly in the initial months of use. However, an increased risk of breast cancer ( 2 ) and an emerging evidence regarding mood disorders and suicide attempts ( 3 – 6 ) arises the question of clinically relevant systemic and in particular psychotropic effects of LNG-IUS. Previous studies investigated ADRs only over a time period of 3 to 5 years after implantation ( 7 – 9 ).…”

Section: Introductionmentioning

confidence: 99%

Depressive Disorder With Panic Attacks After Replacement of an Intrauterine Device Containing Levonorgestrel: A Case Report

et al. 2020

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The levonorgestrel-releasing intrauterine system (LNG-IUS) is used as hormonal contraception by millions of women worldwide. It is considered as a safe device with low rates of systemic adverse drug reactions (ADRs). However, an emerging evidence suggest mood changes as ADRs. Whereas most of these studies report psychiatric ADRs after the first implantation of the LNG-IUS, it has to be considered that these may also occur after replacement, even when psychiatric symptoms were not evident at the time of the initial insertion. A potential explanation for the development of psychiatric ADRs in subsequent LNG-IUS may rely on fluctuations of sex hormones throughout the female life cycle with changing windows of vulnerabilities for developing mood disorders. Thus, the reliable contraception for women remains a continual challenge. We present the case of a 41-year-old woman that used the LNG-IUS (Mirena ®) for contraception over 5 years without any complaints. Within the first weeks after insertion of the second LNG-IUS, she developed a depressive syndrome and anxieties. An extensive somatic, including gynecological examination revealed no pathological findings and a mental disorder was suggested. Due to the patient´s request and the recommendation of her psychiatrist, the device was removed and led to a remission of her mental complaints up to a 6-and 12months follow-up. Beyond the mood changes considerably affecting her quality of life, the patient raised the concerns that she has never been informed about potential ADRs on mental health and her remarks regarding the potential association between psychiatric symptoms and the LNG-IUS were considered as groundless. With this case, we strengthen previous observations regarding mood changes under LNG-IUS. Moreover, we illustrate that psychiatric symptoms may also occur as ADRs during the subsequent insertion. Thus, we emphasize that psychiatric symptoms have to be clearly communicated as ADRs to patients with LNG-IUS within a written informed consent and should be routinely examined by gynecologists.

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Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice

Cited by 25 publications

References 11 publications

Safety of levonorgestrel 52 mg intrauterine system compared to copper intrauterine device: a population-based cohort study

Safety of levonorgestrel 52 mg intrauterine system compared to copper intrauterine device: a population-based cohort study

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

Depressive Disorder With Panic Attacks After Replacement of an Intrauterine Device Containing Levonorgestrel: A Case Report

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