Weighing the risks of valproate in women who could become pregnant

Angus‐Leppan, Heather; Liu, Rebecca S. N.

doi:10.1136/bmj.k1596

Cited by 28 publications

(32 citation statements)

References 44 publications

(36 reference statements)

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“…Despite this, a major concern of consumers was the absence of information about AEs at the time of IUD insertion, particularly hormonal‐related AEs . This lack of information or at least, of efficient information, has been highlighted for other types of care . In the situation herein investigated, it might have played an important role in the massive patient‐reporting that followed the media coverage peak.…”

Section: Discussionmentioning

confidence: 91%

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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Section: Discussionmentioning

confidence: 91%

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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“…There is also broad acceptance that the decisions should be individualised and that “there are likely to be some women who, even after informed consultation, choose to carry a pregnancy while taking valproate.”234 The MHRA recognises that some women with epilepsy cannot stop taking valproate before or during pregnancy without major risk to the person and the unborn child—frequent convulsions and convulsive status epilepticus are potentially dangerous to both.…”

mentioning

confidence: 99%

Valproate, women, and exceptional circumstances

Angus‐Leppan

Shankar

Cock

2018

BMJ

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“…Patients have the right to informed choice based on the risks and benefits . The majority of patients stated that they did not feel involved in the decision‐making process for the choice of AED prescribed.…”

Section: Discussionmentioning

confidence: 99%

“…5,15,16 Ethical considerations are raised, in relation to the right of choice for well-informed women. 16 Informed treatment decisions require detailed counselling at treatment initiation and at preconceptual counselling.…”

Section: Introductionmentioning

confidence: 99%

Treatment decisions in women of childbearing age on valproate

2020

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Introduction There are little data on the understanding and participation of women of childbearing age in decisions about their choice of antiepileptic drugs (AEDs). Valproate carries a risk of major congenital malformations, developmental and behavioural delay. For some, valproate is the only medication to prevent potentially life‐threatening seizures. Materials & Methods This was a cross‐sectional study of two groups of women of childbearing age; 50 taking valproate and 50 controls. Each patient completed a patient questionnaire and structured telephone interview assessing understanding of the risks and benefits of AEDs in relation to pregnancy. Analysis used unpaired two‐tailed t test and chi‐squared test, with Bonferroni correction. Follow‐up at 12 months showed that 8% of the women taking valproate had switched to other medication. Results Hundred patients participated in the study, 89 on AEDs for epilepsy, 4 for migraine, and 7 for both. 55% of participants stated they were not involved in decision‐making. More patients in the valproate group were informed about (64% vs 42%, P < .005), and expressed understanding of (64%vs 32%, P < .001), the risks involved with treatment. 59% of all patients wanted more information. The minority of women surveyed took folic acid (37%) or used contraceptives (29%). Valproate was used following failure of other AEDs to control seizures in 80%. Discussion This in‐depth survey suggests more information is needed for women taking AEDs, using a range of formats. Women taking valproate are better informed than those on levetiracetam or lamotrigine. Information provision on the use of folic acid and contraception needs improvement.

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Weighing the risks of valproate in women who could become pregnant

Abstract: Despite international consensus on the harmful effects of valproate during pregnancy, women should not be denied the human right to make their own decisions after fully informed discussion, say Heather Angus-Leppan and Rebecca Liu

Cited by 28 publications

References 44 publications

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

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

Valproate, women, and exceptional circumstances

Treatment decisions in women of childbearing age on valproate

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