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UK medicines’ regulator investigates unsafe epilepsy drug being given to pregnant women

The UK’s Medicines and Healthcare products Regulatory Agency is investigating cases where an epilepsy drug that can cause birth defects is still being given to pregnant women, repots The Guardian.

The medication has been compared with thalidomide, the controversial anti-nausea drug dished out to pregnant woman some 50 years ago, resulting in thousands of birth defects worldwide.

Sodium valproate is a drug used to treat epilepsy, and by some people with bipolar disorder or migraines. However, it has been linked to an increased risk of birth defects and developmental problems if taken by pregnant women.

The Guardian reports that some unborn babies continue to be exposed to the medication: the latest figures reveal 247 women had exposed pregnancies between April 2018 and September 2021.

According to the Medicines and Healthcare products Regulatory Agency (MHRA), exposure to the drug during pregnancy has declined in recent years, with a report from the valproate registry revealing that the number of pregnant women prescribed sodium valproate fell by 51% between the 2018-19 and 2020-21 financial years.

But an investigation by the (London) Sunday Times has also revealed reports of the drug being issued without information leaflets, or with warnings obscured.

The article, headlined ‘A scandal worse than thalidomide’, said: “Doctors knew in 1973 that the epilepsy drug sodium valproate posed a risk to unborn children — and ordered that warnings be removed from packets. Almost 50 years and 20,000 disabled babies later, it is still being prescribed to pregnant women.”

The drug thalidomide was given to pregnant women in the late 50s and early 60s to counter morning sickness and nausea, but turned out to cause serious birth defects. Thousands of babies were affected and the drug was later withdrawn from the market.

Two years ago (12 August 2020), MedicalBrief reported that the manufacturer of sodium valproate, multi-national pharmaceutical company Sanofi, had been charged with manslaughter in France due to congenital disorders linked to the drug. The indictment filed arose from four infants’ deaths from 1990 to 2014. The babies died after their mothers had taken the drug for epilepsy during their pregnancies. Sodium valproate has been marketed by the company as Depakine since 1967 for the treatment of epilepsy, bipolar disorder and migraine.

Dr Alison Cave, the MHRAʼs chief safety officer, said every woman taking sodium valproate, and their healthcare professional, needed to sign a yearly risk acknowledgment form.

She said: “Valproate use in pregnancy carries significant risks of harm to the baby and it should not be taken by any woman of child-bearing potential unless they have a pregnancy prevention programme in place, which includes use of effective contraception.

“We have also worked with the Department of Health and Social Care to seek views from the UK public on requirements to ensure medicines containing sodium valproate are always dispensed in the original packaging, so that the important safety information on risks in pregnancy is provided with every dispensed prescription.

“If there are examples where this information has not been provided, we would investigate this.”

Matthew Walker, a professor of neurology at University College London and chair of trustees at Epilepsy Research UK, said it was completely unacceptable that women with epilepsy were not being warned of the potential harmful effects of sodium valproate during pregnancy.

“Unfortunately, for some women, valproate is the only drug that successfully controls their epilepsy and more research is needed to identify safe and effective alternatives,” he said.

The Guardian reports this is not the first time sodium valproate has been at the heart of a public health scandal. The drug was one of three interventions that were the focus of the Cumberlege Review, launched by the then health secretary, Jeremy Hunt, in 2018.

The review estimated 20,000 people in the UK had been exposed to the drug as developing babies, with many women reporting not being warned of the risks by their doctors, or being reassured the drug was safe, or told that should their babies subsequently have problems, these could be “fixed”.

After the report, the Valproate Safety Implementation Group was set up. Last year, the NHS sent a letter to all women and girls aged 12 and over who had a current prescription for sodium valproate, flagging the risks for unborn babies.

An NHS spokesperson said the aim of the expert group was to help reduce the use of sodium valproate by women who could get pregnant by 50% next year.

 

The Guardian article – MHRA to look into cases of unsafe epilepsy drug being given to pregnant women (Open access)

 

Sunday Times article – A scandal worse than thalidomide’ (Restricted access)

 

See more from MedicalBrief archives:

 

Sanofi charged with manslaughter over French infant deaths

 

Poorer test results for children exposed to epilepsy drugs in the womb

 

UK MPs call for inquiry into epilepsy drug ‘scandal’

 

Warnings on side effects of epilepsy drug came 40 years too late

 

 

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