- What is Valproate
- Valproate advice / criteria for prescribing in women of childbearing age
- Valproate in pregnancy
- Men taking valproate who want to have children, or are planning to start a family within the next year
- What is Topiramate
- Topiramate criteria / advice for prescribing in women of childbearing age
- Topiramate in pregnancy
What is Valproate
It comes in different forms - sodium valproate, (Brand names: Dyzantil, Epilim, Episenta, Epival) and valproic acid (Brand names: Belvo, Depakote, Dyzantil, Convulex, Syonell).
For both men and women, valproate is prescribed only when two specialists have independently considered/documented there is no other effective or tolerated treatment for bipolar disorder or epilepsy.
Valproate must NEVER be prescribed in pregnancy in bipolar disorder and can only be used in epilepsy if two specialists have independently confirmed that there is no other effective treatment.
Valproate advice / criteria for prescribing in women of childbearing age
Females of childbearing age should not take valproate, but if a woman has no alternative, then she must be advised of the risks associated with its use in pregnancy and the need to avoid becoming pregnant while taking it.
- up to 4 in 10 babies are at risk of developmental disorders
- children exposed to valproate in the womb are more likely to have autism or autistic spectrum disorders.
- some evidence children may be more likely to develop symptoms of attention deficit hyperactivity disorder (ADHD).
- approximately 1 in 9 are at risk of birth defects
- All pregnancy prevention plan (PPP) requirements should be fulfilled:
- an annual risk acknowledgement form (see box ➡️) must be completed and signed, (done annually, ideally by specialist)
- patient given MHRA Valproate PPP leaflet (see box➡️),
- dispensing packs should have pregnancy warning on medication
- Contraception prescribed must be:
- pill, patch, depot, ring with additional barrier methods with regular pregnancy testing, or
- IUD or implant
Valproate in pregnancy
Advise patients that if they become pregnant while using this medicine, they should continue using it and make an urgent appointment (within a few days) with the GP or specialist team.
Men taking valproate who want to have children, or are planning to start a family within the next year
- Must sign an annual risk acknowledgement form (done with specialist at annual visit)
- Should be informed that:
- valproate may cause risk of infertility (reversible if treatment stopped)
- there is a risk of developmental disorders if drug taken 3 months prior to conception (although this is not a very reliable study)
- Discuss the importance of using contraception while taking valproic acid and for at least 3 months after stopping medication.
What is Topiramate
Also known as topiramic acid, its brand name is Topamax.
Topiramate criteria / advice for prescribing in women of childbearing age
Following a major safety review, as of June 2024 the MHRA is introducing new safety measures for topiramate, particularly with regard to its use in women of childbearing potential and in pregnancy.
The use of topiramate during pregnancy can increase the risk to the baby of congenital malformation, low birth weight, intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder.
Therefore, it is contraindicated in females of childbearing age (unless the conditions of PPP are fulfilled), in pregnancy for prophylaxis of migraine, and in pregnancy for epilepsy unless there is no other suitable treatment.
- All pregnancy prevention plan (PPP) requirements should be fulfilled:
- patient given a new PPP Patient Guide leaflet (see box ➡️ ),
- advised to use effective birth control (contraception) at all times during treatment with topiramate and for at least 4 weeks after the last dose,
- informed that topiramate may interact with some hormonal contraceptives, so women should be advised to also use a barrier method.
- An annual risk acknowledgement form (see box ➡️ ) must be completed and signed, (patients should be seen annually for this).
- Dispensing packs should have warning on medication the conditions of the Pregnancy Prevention Programme are fulfilled (for all indications).
- Patient Card - to be given by pharmacists to all female patients who are dispensed topiramate to inform them of the risks.
Topiramate in pregnancy
If patient is using topiramate for epilepsy → advise patient that if they become pregnant while using this medicine, they should continue using it and make an urgent appointment (within a few days) with the GP or epilepsy team.
If patient is using topiramate for migraine prevention → advise patient that if they become pregnant while using this medicine, that they should stop taking it straight away and contact GP.
nhs.uk Valproic acid: medicine used for bipolar disorder, epilepsy and migraine- nhs.uk Sodium valproate: medicine to treat epilepsy and bipolar disorder
- Valproate use by women and girls - GOV.UK (www.gov.uk)
- New pregnancy prevention measures introduced for topiramate - GOV.UK (www.gov.uk)
- Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention Programme - GOV.UK (www.gov.uk)