Pregnancy prevention programmes: valproate and topiramate

Some medicines can seriously harm a baby if taken in pregnancy. The MHRA has set up pregnancy prevention programmes (PPPs) for several, including valproate, topiramate and the oral retinoids (isotretinoin, acitretin and alitretinoin). This guide covers valproate and topiramate, then notes the retinoids.

What a pregnancy prevention programme is

A PPP is a set of conditions that must be met before a medicine is given to a woman or girl who could become pregnant. In the MHRA's wording for topiramate, the aim is that all women of childbearing potential use highly effective contraception, have a pregnancy test to exclude pregnancy before starting, and are aware of the risks. A signed form and written materials support the conversation.

Valproate and topiramate both come with a risk form that the prescriber and patient sign at the start of treatment, and a patient card with key information. The form is signed again at annual review for topiramate, and for women and girls on valproate.

Valproate

Valproate-containing medicines include sodium valproate, valproic acid and valproate semisodium. You may see brand names such as Epilim, Depakote and Convulex on the box.

From the MHRA's valproate guidance on GOV.UK and its Drug Safety Update of 13 February 2025:

• Valproate must not be prescribed to any woman or girl able to have children unless the conditions of the PPP are followed.
• Valproate must not be started in anyone, male or female, under 55 years unless two specialists independently consider and document that there is no other effective or tolerated treatment, or that there are compelling reasons the reproductive risks do not apply.
• Two-specialist review is not required for men already taking valproate.
• Women and girls of childbearing potential who are already taking valproate need a second specialist signature at their next annual review only if they have never been reviewed by two specialists. After that, annual reviews need one specialist.
• In women who take valproate while pregnant, around 1 in 9 babies (11%) will have a birth defect, and about 3 or 4 children in every 10 may have problems with early childhood development.
• Male patients under 55 starting valproate complete a Risk Acknowledgement Form with a healthcare professional, at the start of treatment only.
• As a precaution, the MHRA advises men taking valproate and their female sexual partners to use effective contraception (condoms, plus effective contraception used by the female partner) throughout treatment and for 3 months after stopping. It also advises men not to donate sperm during treatment and for 3 months after stopping.
• Female patients under 55 starting valproate complete an Annual Risk Acknowledgement Form, which is also used at annual review.
• Patients should not stop valproate without discussing it with a specialist.

For pharmacists: the guidance lists a patient card, a pharmacy poster setting out actions for dispensing, and rules introduced in 2023 so that all patients receive the whole pack of valproate with the warnings on the box.

Topiramate

Topiramate is used for epilepsy and for migraine prevention. The MHRA announced its PPP in Drug Safety Update in June 2024. The advice:

• Topiramate should not be used in pregnancy for migraine prevention.
• It should not be used in pregnancy for epilepsy unless there is no other suitable treatment.
• It should not be used in women of childbearing potential unless the conditions of the PPP are met, for all uses.
• Those conditions include a negative pregnancy test before starting, and highly effective contraception through treatment and for at least four weeks after the last dose.
• Topiramate may interact with some hormonal contraceptives.
• The Risk Awareness Form is signed at the start of treatment and at annual reviews.

Advice for dispensers in the same article: the pack carries a warning symbol (a pregnant woman in a red circle with a line through it). Pharmacists should dispense whole packs whenever possible, give the patient card to female patients, and ask women and girls of childbearing potential whether they are using highly effective contraception. If they are not, the pharmacist should advise them to contact their GP for a follow-up appointment.

The oral retinoids

Valproate and topiramate are not the only medicines with a programme. The MHRA's Drug Safety Update of 19 June 2019 says the oral retinoids acitretin, alitretinoin and isotretinoin must not be used in pregnancy, and that any use in women and girls must be within the conditions of a Pregnancy Prevention Programme. The Drug Safety Update of 22 January 2026 on isotretinoin says patients of childbearing potential should continue to be entered into the programme, which also applies to the other oral retinoids, and that healthcare professionals should keep using the patient reminder card and pharmacist checklist. Read both before you revise this group.

What to tell a patient who thinks she is pregnant

This is easy to get wrong, because the safe answer differs by medicine and by reason for use. For topiramate, the MHRA's patient advice is as follows.

• Epilepsy: do not stop topiramate, because the seizures may start again or become more frequent and longer. Make an urgent appointment with the GP or epilepsy team, within a few days.
• Migraine prevention: stop taking topiramate straight away and contact the GP.

For valproate, the guidance says not to stop without first discussing it with the specialist, and to contact the doctor at once if planning a family or pregnant.

A revision routine for any PPP medicine

1. Name the group of people covered: who counts as able to have children?
2. List the conditions: pregnancy test, contraception, signed form, review interval.
3. Note what the pharmacist does at the counter: whole pack, patient card, ask about contraception, refer.
4. Note the "don't just stop" exceptions, and who to contact urgently.
5. Then ask what changes for the same person if she is breastfeeding or over 55, or if the patient is male.

Updates on both programmes appear in the MHRA's Drug Safety Update, so reading it is part of revising this topic. For finding the contraindications and pregnancy information in a medicine's product information, see the SmPC guide.

Sources

• Valproate - reproductive risks, MHRA guidance (GOV.UK), last updated 23 September 2025. https://www.gov.uk/guidance/valproate-reproductive-risks. Accessed 22 October 2026.
• Valproate: review by two specialists is required for initiating valproate but not for male patients already taking valproate, Drug Safety Update, 13 February 2025 (GOV.UK). https://www.gov.uk/drug-safety-update/valproate-belvo-convulex-depakote-dyzantil-epilim-epilim-chrono-or-chronosphere-episenta-epival-and-syonellv-review-by-two-specialists-is-required-for-initiating-valproate-but-not-for-male-patients-already-taking-valproate. Accessed 22 October 2026.
• Oral retinoid medicines: revised and simplified pregnancy prevention educational materials for healthcare professionals and women, Drug Safety Update, 19 June 2019 (GOV.UK). https://www.gov.uk/drug-safety-update/oral-retinoid-medicines-revised-and-simplified-pregnancy-prevention-educational-materials-for-healthcare-professionals-and-women. Accessed 22 October 2026.
• Isotretinoin: changes to prescribing guidance and additional risk minimisation measures, Drug Safety Update, 22 January 2026 (GOV.UK). https://www.gov.uk/drug-safety-update/isotretinoin-changes-to-prescribing-guidance-and-additional-risk-minimisation-measures. Accessed 22 October 2026.
• Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention Programme, Drug Safety Update, 20 June 2024 (GOV.UK). https://www.gov.uk/drug-safety-update/topiramate-topamax-introduction-of-new-safety-measures-including-a-pregnancy-prevention-programme. Accessed 22 October 2026.

The MHRA and GOV.UK pages listed above only: Contains public sector information licensed under the Open Government Licence v3.0.

Share this guide

Not affiliated with the General Pharmaceutical Council. Revision only, not clinical or legal advice. Worked examples use invented numbers and products. Every source above was read on 22 October 2026; check anything that matters against a current source. See our terms of use and privacy notice.