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Written on 15th June 2021 by

NHS England has sent a letter to all women and girls of potential childbearing age who are currently prescribed sodium valproate. The letter provides safety warnings, setting out information that women and girls who are taking the drug should know about the risks to unborn babies in pregnancy, the importance of using contraception, seeking medical advice and regular treatment reviews.

The letter, signed by NHS England and NHS Improvement’s National Director of Patient Safety and Deputy Chief Medical Officer, and National Medical Director, has been sent to women and girls aged from 12 to 55, who are currently prescribed sodium valproate. All are urged to continue their medication, seek medical advice for review of their treatment or advice about pregnancy and, unless specifically exempted by their doctor,  to continue using their prescribed contraception, whether sexually active or not.

What is valproate?

Valproate is an anti-convulsant drug. It is also known by many trade names, including sodium valproate, Epilim, Epival, Episenta and Dyzantil.  It is used to treat epilepsy and is also prescribed as a treatment for people who suffer from bipolar disorder.

Valproate is very effective at reducing epileptic fits or seizures, but when valproate is taken by the mother during pregnancy it carries a high risk of serious physical and neurological injury to the unborn baby. For that reason, in 2018, the prescription of sodium valproate for girls or women of childbearing age was banned, unless no other anti-convulsant medicine can effectively control their epilepsy.

Where valproate is the only effective drug for a girl or woman with epilepsy, GPs, pharmacists and hospital doctors must follow strict guidance, set out in the valproate licensing regulations and NICE guidelines. These guidelines require them to review the patient’s treatment regularly, make sure that they are using contraception under a pregnancy prevention programme (PPP), and warn them of the risk of serious injury to an unborn baby.

Long before 2018, doctors treating women and girls were expected to consider whether alternative treatments to valproate would be effective, and to counsel and warn them about the risks of valproate to unborn babies in pregnancy. However, as the IMMDS Review, ‘First Do No Harm’ highlighted, it was common for women to be left unaware of the dangers of valproate in pregnancy, causing severe avoidable harm to thousands of babies.

Where a doctor has failed to comply with the guidelines relating to warning, reviewing, safeguarding from pregnancy and prescribing valproate treatment, and this results in physical or neurological disability to an unborn baby, the child may be entitled to substantial compensation.

Why has the NHS sent out safety warning letters to women and girls taking valproate?

Babies who are exposed to valproate drugs in pregnancy have around a 10% risk of physical disabilities, such as:

  • minor malformations (small fingers and toes);
  • major malformations:
    • of the spine, (spina bifida);
    • of the face and skull, (cleft palate);
    • of the limbs;
    • of the organs, (heart, kidneys and sexual organs).

They also have up to a 40% risk (four out of every ten babies) of suffering developmental or learning disability.

The combination of an injury and disability that a child suffers from exposure to sodium valproate medication in pregnancy is sometimes known as Fetal Anti-Convulsant Syndrome (FACS).  

Valproate safety warnings - what girls and women should know

Today’s letter from the NHS reminds girls and women taking valproate of what they should already know, if they have been correctly counselled and treated and their valproate medication has been correctly prescribed, dispensed (by their pharmacist) and regularly reviewed.

The letter tells them:

  • They must have a medical review of their treatment every year.
  • They must not stop taking their valproate unless they have spoken to their doctor or nurse.
  • They should not become pregnant while taking valproate. This means that if they are between  12 and 55 years old, they must use contraception, even if they are not sexually active, unless their doctor says they don’t need to.
  • It is important that they know that taking valproate during pregnancy can cause harm to their baby from:
    • birth defects when the baby is born;
    • developmental and learning disability, such as problems with learning to walk and talk, lower intelligence than other children of the same age, and memory problems as the child grows up.
  • If their treatment has not been reviewed in the past year they should:
    • keep taking their valproate;
    • keep using contraception;
    • make an appointment with their doctor or nurse specialist as soon as possible;
    • tell them they need to speak to them about whether valproate is still the best drug for them.
  • If they think they might be pregnant, they must:
    • keep taking their valproate until they talk to their doctor;
    • make an appointment with their doctor as soon as possible;
    • tell them they are pregnant and taking valproate.
  • If they want to try to become pregnant they must:
    • keep taking their valproate until they talk to their doctor;
    • keep using contraception;
    • make an appointment with their doctor as soon as possible;
    • tell them they need to speak to them about valproate and pregnancy.
  • If they are not using contraception that was recommended to them because they take valproate, they must:
    • keep taking their valproate;
    • keep using contraception;
    • make an appointment with their doctor or sexual health clinic as soon as possible;
    • tell them they need to speak to them about pregnancy prevention and valproate.

Claiming compensation for FACS and physical or developmental disability from exposure to valproate

It is vitally important that every woman and girl of potential childbearing age who takes valproate receives and understands this information. If further harm to unborn babies is to be prevented, it is also vitally important that women and girls can easily access clear information,  medical advice and support from their GP, pharmacist or hospital consultant.

We know, however, that in the past, this information has not been made available or properly discussed with patients, leading to unacceptable levels of harm which, with proper care, should have been avoided. For those who have suffered harm, the only way that they can currently receive financial help to manage their disability is to make a claim for compensation.

Boyes Turner’s specialist medical negligence lawyers are currently acting for the families of several children who suffered severe, permanent physical and neurological disability as a result of negligent treatment with valproate.

If you or your child suffered severe injury or disability as a result of negligent exposure to valproate in pregnancy, you can talk to one of our specialist solicitors, free and confidentially, by contacting us at mednegclaims@boyesturner.com.