Sodium valproate campaign

What’s the issue?

Sodium valproate is a medicine used to treat epilepsy. It is often prescribed under the brand name Epilim; however other brand names are also used for valproate medicines. For some people it might be the most effective epilepsy medicine, and the only medicine that helps to control their seizures.

However, sodium valproate carries a higher risk than other anti-seizure medications (ASMs) of causing birth defects and developmental problems in babies if taken during pregnancy.

It is crucial that women do not stop taking their epilepsy medicines without talking to a healthcare professional first. Stopping your medication could be harmful for you, and if you’re pregnant, your unborn child.

If you are worried about any of the issues discussed then please make an appointment with your doctor. For information on planning a baby for women with epilepsy please contact the Epilepsy Action Helpline on freephone 0808 800 5050.

Although there was evidence of the risks of using sodium valproate during pregnancy when it was first licensed in 1972, it was not until very recently that these risks were properly communicated to patients. As a result of the failures to ensure that people with epilepsy were aware of these risks, it is estimated that 20,000 children have been harmed.

In 2013, the MHRA referred sodium valproate to the European Medicines Agency (EMA) for a review. Concerns were raised in response to new data around the effects of taking sodium valproate during pregnancy.

On 24 April 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) changed the licence for valproate medicines in the UK. Sodium valproate must no longer be prescribed to women or girls of childbearing age unless they are on the pregnancy prevention programme (PPP).

As part of the PPP, the prescriber must make sure the woman or girl understands the risk if she became pregnant while taking the medicine. A risk acknowledgement form must be completed by the prescriber and the woman being prescribed valproate based medication. This form must be completed and signed during a review which must take place at least once a year.

The Cumberlege Review

In February 2018, the government announced an independent review into medicines and medical devices safety. The Cumberlege Review looked at three “public health scandals”, including sodium valproate.

Epilepsy Action’s then deputy chief executive Simon Wigglesworth, spoke at the Cumberlege Review, describing the actions Epilepsy Action had taken to highlight the risks of taking sodium valproate. The review published its report “First Do No Harm” on 8 July 2020.

The report includes a number of recommendations which will hopefully greatly improve the support available to families affected by this medication, as well as going some way to address the avoidable harm that has been caused.

The report’s recommendations include:

• An apology from the Government on behalf of the healthcare system to the families affected by valproate

• The creation of a compensation scheme to meet the cost of providing additional care and support to those affected

• The establishment of specialist centres for those affected by medications taken during pregnancy

• Continuing to improve communication of risks to ensure that all women on sodium valproate are aware of the risks before making family planning decisions

• The creation of a registry for all women on anti-seizure medication who become pregnant

Epilepsy Action has called for the creation of a register of women on valproate, as well as financial support for those affected by sodium valproate syndrome, and we were therefore very pleased that these recommendations were included in the report.

However, it has taken a long time to reach this point, and there is still more work to be done. The government responded to the “First Do No Harm” report, and while they accepted some of the recommendations, they rejected others including the proposal to create a compensation scheme for those affected.

It is now important that these recommendations are implemented in full to ensure that all women and girls taking this medication are aware of the risks, and are able to make an informed choice about whether or not to take valproate.

What we are doing

All women who are prescribed sodium valproate must be made aware of the risks. Epilepsy Action also strongly recommends that all women with epilepsy should receive pre-conception counselling. More needs to be done to ensure that healthcare professionals are given the right time and resources to talk to women and girls with epilepsy about pregnancy. Ideally, they must know about the associated risks before they become pregnant.

Epilepsy Action has been working closely with the MHRA and others to ensure that women and girls of childbearing age are aware of the risks. We are also working to reduce the number of pregnancies exposed to valproate medicines to an absolute minimum.

Following the publication of the Cumberlege Review, we are calling on the Government, MHRA and others to fully implement the recommendations.

We have called on the Secretary of State for Health and Social Care to fully implement the recommendations of the Cumberledge Review’s ‘First Do No Harm’ report and urged the government to reconsider their refusal to set up a compensation scheme.

We will be closely monitoring developments to ensure this happens. We will not let this significant opportunity to address this issue be missed.

Other epilepsy medicines

In January 2021, the MHRA and Commission for Human Medicines (CHM) published a review of epilepsy medicines and the safety of using them during pregnancy.

They reviewed the available safety data for epilepsy medicines during pregnancy and found that a number of other epilepsy medicines pose a risk of harming unborn children if taken during pregnancy.

While none of the medicines posed as much of a risk as sodium valproate, using Carbamazepine (brand names Curatil, Tegretol), phenobarbital (brand names Phenobarbital Accord, Phenobarbital Elixir) or topiramate (brand name Topamax) during pregnancy increases the risk of physical birth abnormalities compared with the general population.

Lamotrigine and levetiracetam medicines are safer to use during pregnancy than other epilepsy medicines and they do not increase the risk of physical birth abnormalities compared with the general population.

For the medicines listed below there is not enough information on their use in pregnancy to make any conclusions about their safety when used during pregnancy. This means the risk of harming a baby cannot be confirmed or ruled out.

• Brivaracetam (brand name Briviact)
• Clonazepam (brand names Clonazepam Rosemont, Clonazepam Thame)
• Eslicarbazepine (brand name Zebinix)
• Ethosuximide (brand names Ethosuximide Aristo, Ethosuximide Essential Generics, Ethosuximide neuraxpharm)
• Lacosamide (brand name Vimpat)
• Rufinamide (brand name Inovelon)
• Perampanel (brand name Fycompa)
• Primidone (brand name Primidone SERB)
• Tiagabine (brand name Gabitril)
• Vigabatrin (brand names Kigabeq, Sabril)

Following the MHRA and CHM’s review of other epilepsy medicines and their use in pregnancy, Epilepsy Action are now calling for the risks of taking these medicines to be properly communicated to patients and healthcare professionals.

It is also vitally important that more research is carried out into the medicines listed above for which there is not enough information on their safe use in pregnancy. It cannot be acceptable that people with epilepsy do not have the information about whether or not their medication is safe to use during pregnancy.