Valproate and of risk of abnormal pregnancy outcomes: new communication materials

Children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations. Use the new communication materials below to discuss these risks with patients

In January 2015 we informed you that children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations. To further improve awareness of the risks of valproate in pregnancy we are asking that you use the new communication materials below to support discussion of these risks with women of childbearing potential and girls who take valproate. Hard copies are being sent to relevant healthcare professionals from this week.

Resources to use (see below for more information):

Later in 2016, the outer packaging for medicines containing valproate will include a warning for women on the risk of adverse pregnancy outcomes.

Summary of risks and precautions

  • Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases) refs 1-9
  • Valproate should not be prescribed to female children, female adolescents, women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated.
  • Valproate treatment must be started and supervised by a doctor experienced in managing epilepsy or bipolar disorder.
  • 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.
  • You must ensure that all female patients are informed of and understand:
    • the risks associated with valproate during pregnancy;
    • the need to use effective contraception;
    • the need for regular review of treatment;
    • the need to rapidly consult if she is planning a pregnancy or becomes pregnant

For specialists (neurologists, psychiatrists and paediatricians)

We are asking that you use the following communication materials to help manage and minimise the risks outlined above. If you manage specialist care in your organisation, ensure that processes are in place to allow these requirements to be met.

Read the healthcare professional booklet which gives:

  • a comprehensive overview of the risks of valproate in females of childbearing potential and during pregnancy,
  • points to consider and steps to take when deciding to treat women of childbearing potential and girls with valproate.

Whenever you conclude it necessary to treat or continue treating a woman of childbearing potential or girl with valproate, use the checklist to check that you have given her all the necessary information and that she has fully understood it. Add the completed checklist to her medical records as a permanent record of your discussion.

When considering treating a woman of childbearing potential or girl with valproate, give her or her carer the valproate patient guide and ensure that she understands the information it contains.

Paediatricians should also refer parents or carers to the information about valproate from the Royal College of Paediatrics and Child Health.

For pharmacists

  • Whenever you dispense a medicine related to valproate for a woman of childbearing potential or girl, give her a patient card, unless she confirms that she already has one.
  • Encourage her to read the card (example in figures below) and enter her name and date to reinforce her own accountability to consider the information it contains.
  • If you manage dispensing services in your organisation, ensure that processes are in place to allow these requirements to be met.
  • Please continue to report any suspected side effects to valproate or any other medicine on a Yellow Card (see also guidance on reporting side effects experienced by the woman or child to medicines taken during pregnancy).

For general practitioners

  • Valproate treatment must be started and supervised by a specialist experienced in managing epilepsy or bipolar disorder.
  • Consider the need to arrange treatment reviews with the relevant specialist for women of childbearing potential and girls who are currently taking valproate.
  • If a woman who is taking valproate tells you she is pregnant or would like to have a baby, refer her to the specialist responsible for her care.
  • Please continue to report any suspected side effects to valproate or any other medicine on a Yellow Card (see also guidance on reporting side effects experienced by the woman or child to medicines taken during pregnancy).

Off-label use: risks and advice still apply

Valproate is not licensed for treatment of conditions other than epilepsy or bipolar disorder in the UK. However, we are aware that these medicines are sometimes used ‘off-label’ (eg for migraine or chronic pain). If you are considering initiating or continuing such treatment, the same risks and advice in this article apply.

Monitoring effectiveness of risk minimisation

The effectiveness of the above risk minimisation measures will be continuously monitored via prescribing data and evaluation of levels of patient awareness. Results will be communicated as they become available. As with all medicines, we will continue to monitor the safety and efficacy of valproate to assess the need for further regulatory action.

Further information

Valproate healthcare professional booklet

Valproate consultation checklist

Valproate patient guide

Valproate patient card

Summaries of product characteristics

Letter sent to healthcare professionals in Feb 2016

Drug Safety Update articles on valproate from November 2013 and January 2015

Further information from the MHRA

Epilepsy Action statement 8 February 2016

NICE Guidance for bipolar disorder September 2014

NICE Guidelines for epilepsy January 2012

valproate patient card 2016

Figure 1: front of patient card

back of valpro patient card

Figure 2: back of patient card

Article citation: Drug Safety Update volume 9 issue 6 February 2016: 1.

References

  1. Meador K et al. Lancet Neurol 2013;12(3):244-52
  2. Christensen J et al. JAMA 2013;309(16):1696-703
  3. Veiby G et al. Epilepsia 2013;54(8):1462-72.
  4. Cohen MJ et al. Epilepsy Behav 2013;29(2):308-15
  5. Bromley RL et al Epilepsia 2010;51(10):2058-65.
  6. Cummings et al. Arch Dis Child 2011;96(7):643-7
  7. Meador K et al. NEJM 2009;360(16):1597-605
  8. Thomas S.V et al. Epilepsy Behav 2008;13(1):229-36
  9. Bromley R et al. Cochrane Database of Systematic Reviews 2014, Issue 10

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