Findings from a new registry of valproate use in pregnancy show 180 women were prescribed valproate in a month in which they were pregnant, between April 2018 and September 2020.
NHS Digital and the Medicines and Healthcare products Regulatory Agency (MHRA) are developing Medicines in Pregnancy Registries to monitor the use of medicines like valproate in pregnancy.
Valproate is used to treat some types of epilepsy and for some people is a very effective epilepsy medicine. However, it is well known to cause birth abnormalities and learning and thinking difficulties in babies born to women taking it during pregnancy.
The Independent Medicines and Medical Devices Safety (IMMDS) Review carried out on three medical products concluded that a registry should be set up to monitor the effects of epilepsy medicines used during pregnancy.
The MHRA has said that valproate should not be prescribed to “any woman or girl able to have children unless she is supported by a Pregnancy Prevention Programme (PPP)”. The Medicines in Pregnancy Registry on valproate is looking to monitor the changing use of valproate in women and the implementation of the PPP.
Despite guidance from the MHRA around avoiding prescribing valproate to women or girls being published in 2018, 180 women were subsequently prescribed valproate while they were pregnant. This is out of 462 women or girls who had conceived over the reporting period.
Within the reporting period, 47,532 women and girls were prescribed valproate for one or more months. In September 2020, the majority (89%) prescribed valproate were aged 16-54 years.
However, the findings also showed that there was a general decrease in prescribing of valproate during the reporting period. From the start of the reporting period to the end, there were 5,353 fewer prescriptions for valproate in women and girls.
There were also fewer ‘new starters’ – women and girls who had not been prescribed valproate in the previous 12 months – in September 2020, compared with September 2019. Also, 238 women and girls had their valproate prescription changed to another treatment before they became pregnant.
Louise Cousins, director of external affairs at Epilepsy Action, said: “This new register, while very welcome, has highlighted that some women are still being prescribed valproate while they are pregnant. This is extremely concerning. The evidence that valproate can be harmful to babies if it is taken in pregnancy is well-established and should be well known among the medical community.
“No woman aged between 14 and 45 should be taking valproate to control their epilepsy unless they are supported by a pregnancy prevention programme. Women with epilepsy face complicated decisions if they become pregnant or wish to start a family. They need access to pre-conception counselling, as well as more support with family planning, so that they are supported and able to make informed decisions about their care.
“The important work of the Medicines in Pregnancy Registry needs to continue and expand to cover all epilepsy medicines as was recommended by last year’s Cumberlege review.”
Recent findings suggest that more epilepsy medicines than just valproate can cause a risk of birth abnormalities or learning difficulties in babies if taken during pregnancy. Epilepsy Action is calling for more urgent research into the risks of epilepsy medicines – and taking more than one medicine – in pregnancy.
Valproate medicines include sodium valproate (Epilim, Episenta, Epival, Depakote) and valproic acid (Convulex). You can find more information about valproate and pregnancy on the Epilepsy Action website.
It is important that women do not stop or reduce their epilepsy medicine unless they are advised to do so by their doctor. Stopping or reducing epilepsy medicines could lead to more frequent or more severe seizures. Anyone worried about their epilepsy medicines should speak to their doctor.
UPDATE 12 March 2021: Since this article was published, the Department of Health and Social Care has said it will extend the registry to include women prescribed all epilepsy medicines in the next phase of its development.