Valproate, women, and exceptional circumstancesBMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3625 (Published 28 August 2018) Cite this as: BMJ 2018;362:k3625
- Heather Angus-Leppan, consultant neurologist1,
- Rohit Shankar, consultant in adult developmental neuropsychiatry2,
- Hannah Cock, professor of epilepsy and medical education3
- on behalf of Royal College of Psychiatrists Intellectual Disability Section, the United Kingdom Learning Disability Professional Senate, and 62 signatories
- 1Epilepsy Initiative Group, Royal Free London NHS Foundation Trust, London, UK
- 2Cornwall Partnership NHS Foundation Trust, Bodmin, UK
- 3Atkinson Morley Regional Epilepsy Network, St George’s University Hospital NHS Foundation Trust, London, UK
The Medicines and Healthcare Products Regulatory Agency (MHRA) now requires women of childbearing potential who take valproate to provide annual signed confirmation of adherence to the pregnancy prevention programme. The detail that for “for some women with epilepsy, it may not be possible to stop valproate, and they may have to continue treatment (with appropriate specialist care) in pregnancy”1 is crucial and from our experience seems to be sometimes overlooked.
There is international consensus that valproate is a major teratogen, that alternatives should be offered where possible and safe, and that all women for whom it is considered should undergo specialist review. 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.
In an open letter to the MHRA (box), we have outlined guidance for the exceptional circumstances in which a pregnancy prevention programme is not appropriate, although a risk acknowledgment form would still be required. These include emergency situations; those who make a fully informed decision and whose treating professionals agree that pregnancy prevention is not appropriate; and those with impaired capacity (such as some people with intellectual disability), where a bests interest process has been followed supporting the continuation of valproate. This guidance is endorsed by the Royal College of Psychiatrists Intellectual Disability Section, the United Kingdom Learning Disability Professional Senate, and 62 epilepsy clinicians working in tertiary, secondary, and community care across the country.
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