Women taking valproate still unaware of pregnancy risks, survey finds

One in ten women currently taking valproate are unaware that the medicine can cause birth defects in pregnancy, according to a survey carried out by three epilepsy charities.

In girls or women of childbearing potential valproate should be initiated and supervised by a specialist and only used when other medications are not tolerated or ineffective. | GETTY IMAGES
In girls or women of childbearing potential valproate should be initiated and supervised by a specialist and only used when other medications are not tolerated or ineffective. | GETTY IMAGES

Despite the introduction of more stringent valproate prescribing regulations by the MHRA in 2018, a survey by Epilepsy Action, Epilepsy Society and Young Epilepsy has found that 11% of women taking the drug are unaware of the risk of birth defects if it is used in pregnancy.

Furthermore, 18% did not know that taking valproate during pregnancy can also cause learning and developmental delays in children.

If valproate is taken during pregnancy, up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects.

Survey results

The charities surveyed women and girls who had taken valproate since 1 August 2018.

Almost half (44%) of the 514 respondents said they had not discussed the risks of taking the medicine with their healthcare professionals in the past 12 months, and only 41% said they had signed the mandatory annual risk acknowledgment form.

The charities say they are pushing for more to be done to encourage and resource healthcare professionals, including GPs, to have conversations about the risks of valproate.

Simon Wigglesworth, deputy chief executive of Epilepsy Action, said: 'It’s simply unacceptable that some women with epilepsy are still in the dark about the dangers of taking valproate in pregnancy. Just one woman unaware of the serious impact it could have on her unborn child is one woman too many. With a wealth of resources now available for health professionals to facilitate conversations, there is just no excuse for not explaining the risks to every woman taking valproate. Change needs to happen now to prevent babies being needlessly harmed and the devastating, life-long impact this has on families.'

Pregnancy Prevention Programme

In 2018 the MHRA warned that valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme (PPP) in place. This strengthened measure was intended to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

Healthcare professionals who seek to prescribe valproate to their female patients must make sure they are enrolled in the PPP. The RCGP highlights the following actions as being the responsibility of general practice when implementing a PPP:

  • Ensure continuous use of highly effective contraception in all women of childbearing potential (and consider the need for pregnancy testing if not a highly effective method)
  • Check that all patients have an up to date, signed, risk acknowledgment form each time a repeat prescription is issued
  • Ensure the patient is referred back to the specialist for review annually
  • Refer back to the specialist urgently (within days) in case of unplanned pregnancy or where a patient wants to plan a pregnancy

The MHRA provides a number of PPP materials online to support healthcare professionals, including:

  • Patient card: to be given by pharmacists to all female patients who are dispensed valproate medicines to inform them of the risks
  • Patient guide: to be provided to patients of childbearing potential taking any medicine containing valproate (or their parent/caregiver/responsible person)
  • Guide for healthcare professionals: for all prescribers, pharmacists, and other healthcare providers involved in the care of patients of childbearing potential using valproate medicines

Of the women surveyed, 56 said they had never received any PPP materials. 

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