Valproate in pregnancy: about 1 in 9 babies has a birth defect
Since January 2024 the UK will not start it in anyone under 55 without two specialists signing off.
Top of the evidence hierarchy, independently funded. how we score evidence
This is the starkest number in psychiatric prescribing. If valproate is taken during pregnancy, around 1 in 9 babies — about 11% — will have a birth defect, including spina bifida and malformations of the face, skull and limbs. Separately, around 3 or 4 children in every 10 may have problems with early childhood development: delayed motor skills, reduced intellectual ability, and increased likelihood of autism.
The UK regulator's response since 31 January 2024 is unusually strict. Valproate must not be started in any new patient of either sex under 55 unless two specialists independently document that nothing else works or is tolerated. For women and girls who could become pregnant it is only available under a Pregnancy Prevention Programme with an annual risk acknowledgement form. For men, exposure in the three months before conception is associated with neurodevelopmental conditions in roughly 5 children per 100.
Worth asking
If you are on valproate and could become pregnant or are planning to father a child: why valproate specifically rather than an alternative, and what does switching look like — never stopping it on your own, because abrupt discontinuation carries its own serious risks.
Source
Valproate: reproductive risks — Medicines and Healthcare products Regulatory Agency (MHRA) (2025)
Regulator or national health body
Read the source: https://www.gov.uk/guidance/valproate-reproductive-risks
How this was scored
- Study design
- Regulatory safety determination
- Funding
- No external funding
- Published in
- Regulator or national health body
- Sample size
- not recorded
- Preregistered
- No
- Conflicts disclosed
- Yes
- Independent of proponent
- Yes
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published August 5, 2026. Last verified August 19, 2026.
Questions
How strong is the evidence behind this?
Resolv rates this source "gold standard". Top of the evidence hierarchy, independently funded. It scores 86 out of 100 on our published rubric. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
Valproate: reproductive risks — Medicines and Healthcare products Regulatory Agency (MHRA) (2025). Published in: Regulator or national health body. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Regulatory safety determination. Funding: No external funding. The researchers were independent of whoever benefits from the result. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is valproate (Depakene), divalproex (Depakote), valproic acid FDA approved?
Yes — this medication carries FDA approval. Approval is always for a specific indication, not for every use it is prescribed for.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.