Valproate - why we must weigh up the benefits along with the risks

Nicola Swanborough unpicks the issues around valproate and explains why the risks and benefits of the medication must be properly discussed and evidenced in public, before new prescribing practices potentially put people with epilepsy at risk of seizures

Sodium valproate is complicated. On the one hand it is one of the most effective epilepsy medications for controlling seizures. On the other hand – and significantly – almost half of babies exposed to the drug during pregnancy are born with a physical abnormality or neurodevelopmental disorder.

The Epilepsy Society, along with other charities and patient organisations, has actively campaigned for greater awareness of the risks linked to valproate. This has resulted in new and important guidance around the prescribing of valproate to women and girls of childbearing age. No woman in this age bracket should now be prescribed valproate unless a Pregnancy Prevention Programme is in place and she has signed a risk awareness form.

This is to stop babies being born with avoidable disabilities. 

New prescribing practices

However, this month, new prescribing practices for valproate have been introduced and include men and boys under the age of 55. And they have slipped in under the wire, without consultation.

Introduced by the medicines regulator, the MHRA, changes mean that anyone under the age of 55 (men and boys, women and girls) can only be prescribed valproate if two epilepsy specialists have confirmed and documented  in writing that there is no suitable alternative.

Doctors are being advised not to start newly diagnosed patients on valproate. And, where possible, to switch patients from valproate to another treatment. 

Fertility in men

The new guidance follows a safety review which shows there is evidence to suggest valproate may affect fertility in men. Some animal studies show adverse effects of valproate on the testes of juvenile animals as well as transgenerational effects.

The MHRA says it currently does not know what this means for humans as it’s not always possible to be sure that an effect seen in animals will be the same in a person taking a medicine. 

But this information has been included in the product information since 2011, so the Epilepsy Society, along with other leading UK epilepsy charities and organisations, want to know why now, and why no consultation?

Risk of seizures

We believe the hurriedly introduced blanket approach could put people at risk of seizures, overwhelming an already over stretched NHS and  potentially compromising the time which should be spent ensuring that all women are aware of the risks around valproate and have been properly counselled about pregnancy.

A prescription for valproate will now mean signatories from two specialists when doctors are already buckling at the knees to see their current patients.

We are concerned that boys and men who have good seizure control on valproate – often after a trial of other drugs which have proved less effective for them – will be once again at risk of seizures as they are switched to a different medication or combination of drugs.

One seizure can cost a driving licence, can impact education, employment, relationships and, of course, seizures can be fatal. As we see it, the evidence for the policy - or all that has been shared so far - is not strong enough to merit the risks it is generating. We would like to see the evidence which has led to this policy change.

Lack of consultation

The charities and the people we support have not been consulted on the new prescribing practices and nor has the Commission on Human Medicines Sodium Valproate Expert Working Group. Our Chief Executive, Clare Pelham, is a member of the group and has spoken openly with the MHRA about the lack of consultation.

The 11-strong coalition is asking the MHRA to pause and review the policy and to share the data on which the new practices have been based. A Freedom of Information request has been submitted but we have basically been told to wait.

It feels as though we have been pushed back into the dark ages with decisions being made behind closed doors and with no patient involvement. We have been banging furiously on the doors of bureaucracy but no-one is listening. 

Less than three years ago in her landmark “First Do No Harm” review, Baroness Cumberlege reminded the healthcare system – including its regulators – that patients were its raison d’etre and should be heard.

How easily they turn a deaf ear.

IMPORTANT: You should never stop taking your medication without first consulting your doctor. To do so, could leave you at risk of seizures.