UK fails to protect babies from sodium valproate side effects

Sodium valproate side effects are severe in pregnancy – but recent data reveals that the epilepsy drug is still prescribed in the UK, despite past evidence of birth defects

Sodium valproate – also known as Dyzantil, Epilim, Episenta and Epival – is used to treat epilepsy and bipolar disorder, with occasional use to prevent migraine headaches.

The drug should definitely not be given to pregnant women. Based on recent European research reviews and legal claims brought in the 1990s against the NHS, sodium valproate is openly, medically understood to be harmful to developing babies.

But recent data from the Medicines and Healthcare products Regulatory Agency (MHRA) finds that 222 pregnant women were exposed to sodium valproate, in the time period of 2020-2021.

20,000 babies are known to have birth defects due to sodium valproate

In the UK, this medicine is only available via prescription. However, sodium valproate has been known to cause issues in pregnancy – particularly for developing babies in the womb. Birth defects, such as neurological issues and physical disabilities, can be created by the use of the drug by pregnant women.

The 2020 Cumberlege Review, which exposed public health issues such as valproate, Primodos and pelvic mesh, found that atleast 20,000 babies had been harmed by the specific use of the epilepsy drug. This is the known number of babies born with defects, but more cases are expected to have slipped under the radar across the UK.

The Cumberlege Review, also known as First Do No Harm, said: “Mothers are burdened by the guilt of having taken tablets during pregnancy. Mothers who took sodium valproate during pregnancy to manage their seizures without knowing the risks this could pose for their unborn children.”

In 2018, the MHRA issued a warning that no pregnant individual should be prescribed this drug.

Healthcare professionals are today – as of the 2018 MHRA guideline – expected to place fertile patients of the drug on a pregnancy prevention programme (PPP). There are three elements to the PPP, highly effective contraception, an annual review by a specialist, and counselling about the risks of valproate.

This includes the signing of a risk assessment document for sodium valproate side effects.

Dr June Raine, Director of MHRA’s Vigilance and Risk Management of Medicines Division said: “If valproate is taken during pregnancy, up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects.”

What are sodium valproate side effects for developing babies?

For those who are pregnant, as Dr Raine highlighted, the risk is relatively high for either a developmental disorder or birth defect.

Some common birth defects are:

1. Spina bifida (where the bones of the spine do not develop properly);
2. Facial and skull malformations (including cleft lip and palate, where the upper lip or facial bones are split);
3. And malformations of the limbs, heart, kidney, urinary tract and sexual organs.

On the neurological side, babies can experience developmental issues:

1. Being late in learning to walk and talk;
2. Lower intelligence than other children of the same age;
3. Poor speech and language skills;
4. And memory problems.

Children who are exposed to the drug while in the womb are also more likely to have Autism or Autistic Spectrum Disorder.

Patients lack ability to make informed choices about their pregnancy

While the 2018 PPP guideline suggests there is a strong framework to prevent birth defects, the reality is starkly different.

In the 2020 Cumberlege Review, the authors find that the majority of pregnant individuals were given little understanding of the risks of their treatment, with any birth defect issues described as things that could be “scanned for and fixed.”

The authors pushed for more detailed insight on risk for all patients, so people could make informed choices.

They wrote: “For example, talking about developmental delay or a six point deficit in IQ for a valproate affected child may sound manageable but fails to convey the reality that the child might never grow up to live independently.”

This revelation about the contemporary use of sodium valproate comes at a time that the UK is experiencing excessive maternal health issues.

The 2020 MBRRACE-UK report ‘Enquiries into Maternal deaths and morbidity’ found that Black women are statistically four times more likely to die during childbirth than white women in the UK.

These figures paint a damning image of pregnancy outcomes across the country.