Benefits and risks of anti-seizure medicines in pregnancy

Benefits and risks of anti-seizure medicines in pregnancy

This material has been supplied by ACC
ACC
ACC

New information resources about the benefits and risks of anti-seizure/mood stabilising medicines for people who could become pregnant is now available.

The resources were developed by a panel of medical experts and consumers, and endorsed by ACC, the Health Quality and Safety Commission, the Ministry of Health, and Foetal Anti-Convulsant Syndrome New Zealand.

Understanding the risks

It is clearly established that anti-seizure/mood stabilising medicines are associated with congenital malformations (such as spina bifida, cleft palate, and heart defects), and cognitive impairment and behavioural difficulties (such as Autism Spectrum Disorder).

When a child has dysmorphic features combined with other malformations some people use the term Fetal Anticonvulsant Syndrome (FACS).

The risks vary depending on the medicine. Some, particularly sodium valproate, carry very high risks that are dose-dependent.

  • 24 out of 100 babies exposed to more than 1500mg of sodium valproate will have malformations such as spina bifida, cleft palate, and heart defects.
  • Between 4 and 15 out of 100 babies exposed to more than 800mg of sodium valproate per day will have autism.
  • Between 30 and 40 out of 100 babies exposed to more than 800mg of sodium valproate per day will have developmental delays.

Watch the video below to find out more about the impact of FACS.

Supporting patients

While the dose or type of anti-seizure/mood stabilising medicine can’t always be altered, clear information is still very important to help people make an informed decision.


“It’s important that people who take these medicines and could become pregnant fully understand the risks and benefits, whether they are planning pregnancy or not,” says ACC’s Chief Clinical Officer, Dr John Robson.


“That’s why we have worked with our partner health agencies and medical experts to ensure the latest information about these medicines is widely available. We encourage dispensers and prescribers of these medicines to ensure their patients have the information they need to make the right decision for them.”

Available resources

Two booklets have been created — one for health professionals and one for people taking the medicines, as well as a flyer suitable for waiting rooms. These can be viewed and ordered at no cost on ACC’s website.

References

[i] Pennell PB. Prescribing antiepileptic drugs to women of reproductive age. Lancet Neurol 2018;17:485–6. http://dx.doi.org/10.1016/S1474-4422(18)30154-6

[ii] Clayton-Smith, J., Bromley, R., Dean, J. et al. Diagnosis and management of individuals with Fetal Valproate Spectrum Disorder; a consensus statement from the European Reference Network for Congenital Malformations and Intellectual Disability. Orphanet J Rare Dis 14, 180 (2019). https://ojrd.biomedcentral.com/articles/10.1186/s13023-019-1064-y

Macfarlane, A., & Greenhalgh, T. Sodium valproate in pregnancy: what are the risks and should we use a shared decision-making approach? US National Library of Medicine, National Institutes of Health. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5984824/

[iii] Prevent Valproate Pregnancy Prevention Programme. Information on the risks of valproate (Epilim, Depakote, Convulex, Episenta, Epival, Kentlim, Orlept, Sodium Valproate, Syonell, Valpal & Belvo) use in girls (of any age) and women of childbearing potential. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/708850/123683_Valproate_HCP_Booklet_DR15.pdf

Mandatories

The resources were developed by a panel of medical experts and consumers, and endorsed by ACC, the Health Quality and Safety Commission, the Ministry of Health, and Foetal Anti-Convulsant Syndrome New Zealand