A government committee said it is ‘unacceptable’ that children are still being born to mothers who were not properly advised about the dangers of taking sodium valproate.

The House of Commons Health and Social Care Committee has called for the government to ensure a ‘rigorous system’ is in place to prevent ‘standards slipping’ when it comes to prescribing the drug, used to treat epilepsy and bipolar disorder and occasionally to prevent migraine headaches.

Sodium valproate can cause birth defects in around one in 10 babies born to those taking it while pregnant, and developmental problems in 30 to 40 per cent of children whose mothers took the medicine while pregnant.

The committee’s report, published on 20 January, is a follow-up on the Independent Medicines and Medical Devices Safety (IMMDS) review, and the government response to this.

It said: ‘It is unacceptable that children are being born to mothers who were not properly advised and supported to change their medication to one less likely to harm their unborn child. There have been important improvements made, but we are concerned that unless the Government ensures there is a rigorous system in place, standards might slip.’

The committee heard from Emma Murphy, from In-FACT, a charity providing information, advice and support to anyone who has taken anti-epileptic drugs in pregnancy and the national campaign group for sodium valproate, providing long-term support for those affected.

Emma was diagnosed with epilepsy aged 12.

She said: ‘I was started on sodium valproate and pretty much just left on it, to be honest. When it came to starting a family, my husband and I questioned at every appointment whether valproate would harm during pregnancy. We were never warned at all. I was always told that it is the safest medicine to take during pregnancy to control the seizures.

‘I now obviously have five children affected, and they are all diagnosed with foetal valproate spectrum disorder, along with autism.’

Since April 2018, 286 women have been prescribed sodium valproate while pregnant, of which 17 of these were identified as ‘new additions’ in the most recent data from October 2021 to March 2022.

The committee said this was ‘worrying’ adding: ‘Some of those 17 women are likely to give birth to children harmed by the teratogenic effects of this medication.

Janet Williams, from In-FACT, told the committee that a pregnancy prevention programme, meant to be in place to minimise the risk of a woman on sodium valproate becoming pregnant, had not ‘got going’, despite it being in place since 2018.

She said women were still approaching the charity to say they had not been called in, or they have had an appointment with a doctor but the topic has not been raised.

She added: ‘There are ladies out there who do not have an epilepsy review or a bipolar review, so the information is not getting through.’

In December 2022, Caroline Noakes MP led a debate on fatalities relating to foetal valproate spectrum disorder (FVSD), which detailed the case of Jake Aldcroft, who aged 21 died after an infection triggered by problems with his kidneys.

Jake was the first person to ever had had FVSD listed as a contributing factor of death on the coroner’s report.

His mother said that she was never advised that taking sodium valproate whilst pregnant may cause harm to her unborn child.

The committee said that, although the number of women on sodium valproate whilst pregnant is decreasing year on year, the effect the drug continues to have on thousands of children and some adults is ‘devastating’.

‘Our thoughts remain with the families affected, who are continuing to battle the harmful effects,’ it said.

A letter sent to the committee from In-FACT said some families affected by FVSD report seeing second-generation problems.

The result of European-commissioned studies into the transgenerational effects of sodium valproate is expected to be published by the end of this year.

However, the committee said it is concerned that data has not been collected in the UK.

It said: ‘We cannot understand how it is not in the interest of the government to monitor transgenerational effects in those affected here in the UK and would welcome an explanation from the minister on this.

‘This lack of data collection and long-term effects monitoring is something we are especially concerned about.’

It said the absence of data represents a ‘serious risk to patient safety’.