Valproate, women, and exceptional circumstances

Angus‐Leppan, Heather; Shankar, Rohit; Cock, Hannah R.

doi:10.1136/bmj.k3625

Cited by 10 publications

(11 citation statements)

References 2 publications

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“…European respondents consider a wide range of exceptional circumstances in which the prescription of VPA is necessary and appropriate in this population (Table 2). The exceptional scenarios raised are consistent with the expert opinion consensus amalgamated in the UK 14 …”

Section: Resultssupporting

confidence: 79%

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Valproate prescribing practices for women with intellectual disability across Europe

et al. 2020

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Valproate (VPA) is an established teratogen with an estimated risk of 10% major congenital malformation (MCM) and up to 40% neurodevelopmental disorders including autistic traits and cognitive deficits. 1,2 The VPA MCM risk is influenced by dose and polypharmacy. 3 Foetal anticonvulsant syndrome (FACS) and VPA embryopathy are defined by developmental delay, attention deficits and intellectual disability (ID). 4,5 In February 2018, the European Medicines Agency (EMA) recommended that VPA should only be used in women of childbearing age if they have epilepsy that does not respond to other AEDs, and if they are enrolled in a pregnancy prevention programme ("PREVENT"). One month later, the Coordination Group for Mutual

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Section: Resultssupporting

confidence: 79%

“…The exceptional scenarios raised are consistent with the expert opinion consensus amalgamated in the UK. 14 (Table 3).…”

Section: Qualitative Datamentioning

confidence: 99%

Valproate prescribing practices for women with intellectual disability across Europe

et al. 2020

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“…In the UK, since 2018 the Medicines and Healthcare products Regulatory Agency (MHRA) mandate the completion of a Valproate Risk Acknowledgement Form (RAF) by an appropriate specialist in all females of childbearing potential who are taking valproate 4 . There are no studies evaluating implementation challenges, the uptake of this initiative and the views of patients and clinicians using the form 5‐7 . The impact of changing from valproate to other medications, or avoiding valproate in females, has not been systematically assessed.…”

Section: Introductionmentioning

confidence: 99%

Valproate risk form—Surveying 215 clinicians involving 4775 encounters

et al. 2020

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Objectives: Annual completion of a Valproate Risk Acknowledgement Form (RAF) is mandated in the United Kingdom due to neurodevelopmental risks of in utero valproate exposure. The number of women of childbearing potential taking valproate, the uptake of the RAF within this population and their clinical outcomes is not known or monitored. This study surveyed responses of clinicians administering the RAF to women of childbearing potential taking valproate medications. Materials and Methods: Study design-national online survey distributed to clinical specialists throughout the United Kingdom via their national organizations. Participants-clinicians qualified to counsel and administer the valproate RAF (as defined by the Medicines and Healthcare products Regulatory Agency). Main outcome measures-quantitative and qualitative responses regarding identification, uptake, effects and reactions to the RAF. Trial registration-registered at the Clinical Governance and Audit Committee at Royal Free London NHS Foundation Trust Hospital.Results: 215 respondents covering more than 4775 patient encounters were captured. Most patients continued on valproate, 90% with epilepsy as the indication.Respondents reported that seizure control deteriorated when switched to levetiracetam (33%) and lamotrigine (43%), compared to 7% when continuing valproate (P < .001).Conclusions: 33%-43% of clinicians reported seizure control deterioration in women changed to alternatives to valproate. Informed consent requires women considering a change are given this information. Systematic capture of data automated through online RAFs and linked to patient outcomes is needed. There remains little data on valproate given for indications other than epilepsy.

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“…There is a consensus of opinion (the Royal College of Psychiatrists Faculty of Intellectual Disability Psychiatry, the United Kingdom Learning Disability Professional Senate, and 61 signatories) on exceptional circumstances in which valproate prescription may be necessary, and participation in the Pregnancy Prevention Programme may not be appropriate. 7 The MHRA regulations recognise that for some women stopping valproate prescription in pregnancy may confer considerable risk to both the mother and the fetus, including death. In such circumstances it may be more appropriate to continue treatment in pregnancy under specialist care.…”

Section: When Valproate May Still Be Appropriatementioning

confidence: 99%