Valproate and Birth Defects - Lessons from the UK

Valproate and Birth Defects - Lessons from the UK
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Valproate is a treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. There has been increasing concern about the relationship between birth defects and the use of this common and effective medication for the treatment of epilepsy and bipolar disorder.

This has led to an alert being sent to all family doctors in the UK, and patients and physicians in the USA can also benefit from this useful advice and the video above which is available from the Royal College of General Practitioners UK and the UK Medicines & Healthcare products Regulatory Agency (MHRA)

What are the issues?

According to the MHRA, around 10% of babies may have a birth defect, and about 30% of babies may have problems with development if their mothers have been prescribed Valproate during pregnancy.

The type of problems that have been reported in babies born to women who have taken Valproate in pregnancy include:

  • spina bifida (where the bones of the spine do not develop properly)
  • facial and skull malformations (including cleft lip and palate, where the upper lip or facial bones are split)
  • malformations of the limbs, heart, kidney, urinary tract and sexual organs
  • being late in learning to walk and talk
  • lower intelligence than other children of the same age
  • poor speech and language skills
  • memory problems
  • autism or autistic spectrum disorders

What can we do?

Valproate is prescribed by physicians all over the world because it is a useful medicine, so this is a global public health issue that requires all of us to play our part because we may be able to reduce the risks to the unborn child.

The UK MHRA has provided some useful advice that all doctors who see young women taking Valproate need to be aware of, and family doctors that pescribe Valproate to prenant women should work in close partnership with patients and their specialists to minimise the risks that Valproate poses to the unborn child.

What patients can do

A Valproate Patient Guide is available (http://www.medicines.org.uk/emc/RMM.421.pdf) and any woman of child bearing age should read this.

The key messages are that:

  • Women taking Valproate should use reliable contraception to avoid an unplanned pregnancy
  • Women who are taking valproate should speak to their doctor if they are planning to get pregnant
  • Women who fall pregnant whilst taking Valproate should tell their family doctor immediately, but must not stop taking the Valproate until advised to do so by their doctor

The role of the family doctor

Collaborative care between the family doctor, the specialist and the patient is an essential part of the management of women of childbearing age who are prescribed Valproate for the treatment of epilepsy or bipolar disorder.

The UK MHRA has issued a useful prescriber checklist (http://www.medicines.org.uk/emc/RMM.423.pdf) and recommend that family doctors should:

  • Identify all women of childbearing age who they prescribe Valproate to and invite them for a review, ensuring that they involve the woman’s specialist care team in the patient managment plan
  • Ensure that women of childbearing age who are prescribed valproate are taking appropriate contraceptive measures to avoid unplanned pregnancy
  • Provide each patient with the Valproate Patient Guide so that women prescribed Valproate are fully aware of the risks, the benefits and the actions that they need to take and document this in the patient record
  • Urgently refer any pregnant woman prescribed Valproate to the specialist responsible for their care so that an appropriate plan for prescribing in pregnancy can be made

The role of the specialist

The UK MHRA recommends that:

  • Valproate treatment must be started and supervised by a doctor experienced in managing epilepsy or bipolar disorder in a woman of child bearing age
  • The specialist must carefully balance the benefits of Valproate treatment against the risks when prescribing Valproate for the first time, at routine treatment reviews, when a female child reaches puberty and when a woman plans a pregnancy or becomes pregnant.

If we can adopt the recommendations about prescribing Valproate in women of childbearing age we can significantly reduce the risk to the unborn child - so let’s all play our own part.

References

  1. https://www.gov.uk/drug-safety-update/valproate-and-developmental-disorders-new-alert-asking-for-patient-review-and-further-consideration-of-risk-minimisation-measures
  2. Bromley R, Weston J, Adab N et al. Treatment for epilepsy in pregnancy: neurodevelopmental outcomes in the child. Cochrane Database Syst Rev. 2014, Issue 10

Professor Gabriel Ivbijaro MBE JP

MBBS FRCGP FWACPsych MMedSci MA IDFAPA

President WFMH (World Federation for Mental Health), Chair The World Dignity Project, Medical Director The Wood Street Medical Centre, 6 Linford Road, Walthamstow, London E17 3LA, UK

Twitter@IvbijaroGabriel facebook.com/IvbijaroGabriel

www.worlddignityproject.com http://www.huffingtonpost.com/author/gabrielivbijarogmailcom

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