Charity tells health secretary new drug regulations could fail without public campaign

Epilepsy Society today welcomes new regulatory measures to stop babies being born with avoidable disabilities after being exposed to the drug, sodium valproate, in the womb.

epilepsysociety.org.uk/sodium-valproate-guidelines

The epilepsy drug, prescribed to around 28,000 women in the UK each year, has a risk of up to 40 per cent of causing physical disabilities or developmental problems for babies exposed to it during pregnancy.

But the charity cautions that unless the regulations are backed by a public communications campaign, the long-fought-for measures may not reach those women and girls who have no option but to take the drug.

Letter to Jeremy Hunt

In a letter to health secretary Jeremy Hunt, the charity's chief executive Clare Pelham paid tribute to how much his personal commitment had meant to the campaign. She went on to say: "It has taken many years to achieve these simple, straightforward and inexpensive healthcare improvements that will prevent babies being born with avoidable disabilities.

"All credit to the brave women who have campaigned for decades.  And to Jeremy Hunt for acting on that campaign and insisting the NHS must now learn from its failure to listen and act sooner in response to the concerns raised over many years and during many governments."

Need for wider communications

But she said she was concerned that the Medicines and Healthcare products Regulatory Agency had not planned a wider public communications programme to raise awareness.

"It is not simply a question of resources but rather a failure to learn the lessons of ineffective communications in the past.  Following an earlier 'toolkit' issued to patients by the MHRA, surveys by the Epilepsy Society, Young Epilepsy and Epilepsy Action showed that 70 per cent of the target audience of women prescribed sodium valproate had not received it."

Review into handling of concerns around sodium valproate

In his statement to the House of Commons preceding these changes, Jeremy Hunt said "our regulatory system is, in many ways, world-leading, but it too needs to adapt to a changing environment and to draw intelligently on multiple sources of feedback to protect the safety of patients." And he asked Baroness Julia Cumberlege to look into "whether the regulators and NHS bodies did enough to engage with those affected to ensure their concerns were escalated and acted upon."

One important change today is that every woman and girl of child-bearing age who has been prescribed sodium valproate will be able to see her doctor every year to discuss the risks of this drug to an unborn baby.  She will leave the discussion with an important written reminder of the risks if sodium valproate is taken during pregnancy.  This means that she will be able to make informed choices about whether to plan a pregnancy and her future medical treatment.

It is important that no woman should stop taking sodium valproate without first consulting her doctor.

Sodium valproate is available in the UK under brand names such as Epilim, Epival, Episenta and Convulex.

To read more about the new prescribing regulations for sodium valproate, see epilepsysociety.org.uk/sodium-valproate-regulations