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

Langlade, Claire; Gouverneur, Amandine; Bosco‐Lévy, Pauline; Gouraud, Aurore; Pérault‐Pochat, Marie‐Christine; Béné, Johana; Miremont-Salamé, Ghada; Pariente, Alexandre

doi:10.1111/bcp.14027

Cited by 12 publications

(11 citation statements)

References 24 publications

(60 reference statements)

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“…This birth control product contains a hormone called levonorgestrel. In 2017, concerns regarding ADRs associated with the use of levonorgestrel releasing intra-uterine device (IUD) started to grown with a media coverage peak occurred in May 2017, which resulted in a massive wave of ADRs reports from patients to French RCPVs (Langlade et al, 2019). Also, Lévothyrox ® has been marketed in France for about 40 years as a treatment for hypothyroidism and, in 2017, a new formula was introduced on the market.…”

Section: Protocol and Datamentioning

confidence: 99%

Co-clustering of evolving count matrices with the dynamic latent block model: application to pharmacovigilance

et al. 2022

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The simultaneous clustering of observations and features of datasets (known as co-clustering) has recently emerged as a central topic in machine learning applications. However, most models focus on continuous data in stationary scenarios, where cluster assignments do not evolve over time. We propose in this paper the dynamic latent block model (dLBM), which extends the classical binary latent block model, making amenable such analysis to dynamic cases where data are counts. Our approach operates on temporal count matrices allowing to detect abrupt changes in the way existing clusters interact with each other. The time breaks detection is performed through clustering of time instants, that allows for better model parsimony. The time dependent counting data are modeled via non-homogeneous Poisson processes (HHPPs), conditionally to the latent variables. In order to handle the model inference, we rely on a SEM-Gibbs algorithm and the ICL criterion is used for model selection. Numerical experiments on simulated data highlight the main features of the proposed approach and show the interest of dLBM with respect to related works. An application to adverse drug reaction in pharmacovigilance is also proposed, where dLBM was able to recognize clusters in a meaningful way that identified safety events that were consistent with retrospective knowledge. Hence, our aim is to propose this dynamic co-clustering method as a tool for automatic safety signal detection, to support medical authorities.

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Section: Protocol and Datamentioning

confidence: 99%

Co-clustering of evolving count matrices with the dynamic latent block model: application to pharmacovigilance

et al. 2022

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“…However, differential under-reporting, i.e., more reporting of POF cases for HPV vaccines compared to other vaccines, may have spuriously inflated the strength of the signal. Greater reporting of POF cases associated with HPV vaccines may have been caused by the novelty of the vaccine compared to the other vaccines, or by media/literature coverage, as found for other products [ 27 ]. Such an increase may have been due to greater scrutiny in the time period following marketing of new vaccines, referred to as the Weber effect [ 16 ], or following the publication of the VSD study in 2014 [ 4 ].…”

Section: Discussionmentioning

confidence: 99%

Human Papillomavirus Vaccination and Premature Ovarian Failure: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System

Tatang

Bisonó

Bergamasco

et al. 2021

Drugs - Real World Outcomes

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Introduction There have been public health concerns about a potential association between human papillomavirus (HPV) vaccines and premature ovarian failure (POF) in young women. Objective To identify a potential safety signal of POF after HPV vaccination using the United States (US) Vaccine Adverse Event Reporting System (VAERS) database. Methods We manually selected relevant MedDRA preferred terms related to POF and identified in VAERS all POF reports in women less than 40 years of age between 2 July 1990 and 14 May 2018, followed by a review of narratives to confirm the cases. We conducted descriptive analyses on age, POF type, HPV vaccine type (HPV2, HPV4, HPV9), time to onset of POF, and dose rank. We described trends in reporting over time and assessed a potential safety signal using the proportional reporting ratio (PRR). Results Of the 228,341 eligible POF reports, 281 (0.1%) were suspected to be associated with HPV vaccines. Median patient age was 15 years (range 11-39 years). POF events consisted mainly of amenorrhea (80.4%) and premature menopause (15.3%). Mean number of reported POF events significantly increased after the first HPV vaccine launch in 2006 with 22.2 POF cases/year up from 1.4 POF cases/year before the launch. PRR was 46.1 (95% confidence interval: 31.7-67.2) and sensitivity analyses yielded similar estimates. Conclusion Our study suggests the presence of a potential safety signal of POF associated with HPV vaccination, which may only be partly attributed to notoriety bias. Due to the well-known limitations of spontaneous reporting data, further investigations are warranted.

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“…При генетической предрасположенности провоцирующим фактором выпадения волос у женщин может выступать нарушение соотношения эстрогенов и андрогенов [12]. Комбинированные оральные контрацептивы или гормонозаместительная терапия прогестагенами с андрогенной активностью (норэтистерон, левоноргестрел, тиболон) часто вызывают облысение, особенно у генетически предрасположенных женщин [1,[13][14][15]. В подавляющем большинстве случаев после отмены оральных контрацептивов отмечается сильное выпадение волос, при этом нередко возникает АГА, что заставляет отказаться от идеи назначения этих препаратов для лечения алопеций (не говоря уже о других побочных эффектах -изменении реологии и липидного профиля крови, повышении уровня глобулина, связывающего половые гормоны, супрессии синтеза гонадотропинов гипоталамусом, акне, гирсутизме, снижении либидо, остеопорозе, нарушении функции надпочечников, нарушении венозного оттока, сухости слизистой влагалища) [1,16].…”

Section: эстрогеныunclassified

Alopecia and Clinical Presentation of Endocrinopathies: Pathogenetic and Diagnostic Aspects

Праскурничий

Gracheva

Куган

et al. 2021

Arhivʺ vnutrennej mediciny

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The review examines the key aspects of the pathogenesis of alopecia in endocrine system pathology. The role of hormones, growth factors, cytokines and other biologically active substances has been demonstrated. Alopecia is a frequent symptom that can be the result of not only gerontological, but also endocrinological problems. Therefore, time-consuming differential diagnosis is often necessary. Diagnosis is more effective if a team of specialists is involved: endocrinologist, gynecologist, andrologist, dermatologist / trichologist, and others.

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

Cited by 12 publications

References 24 publications

Co-clustering of evolving count matrices with the dynamic latent block model: application to pharmacovigilance

Co-clustering of evolving count matrices with the dynamic latent block model: application to pharmacovigilance

Human Papillomavirus Vaccination and Premature Ovarian Failure: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System

Alopecia and Clinical Presentation of Endocrinopathies: Pathogenetic and Diagnostic Aspects

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