Sodium valproate banned without a pregnancy prevention programme

Statement / comment
24 April 2018

April 24 2018: To protect public health, the Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licence for valproate medicines (Epilim, Depakote and other generic brands). Valproate must no longer be prescribed to women of child bearing potential unless she is on a pregnancy prevention programme (PPP).

Dr Angelika Wieck, Royal College of Psychiatrists Perinatal Faculty and Consultant Psychiatrist, Central Manchester University Hospital

"Banning the use of Valproate in women who are pregnant, or who could get pregnant, is welcome given the harm its use can have on unborn children. It cannot be stressed enough that no women should stop taking this medication without medical advice. 

“Managing mental health is particularly important for women who are pregnant or plan to get pregnant. It is essential that all women are better informed about the risks of Valproate to unborn children and that any use of this drug in pregnancy will be monitored.”

“RCPsych will work with the MHRA and other Government bodies, the Royal Colleges of General Practitioners, Physicians, Obstetricians and Gynaecologists and the Royal Pharmaceutical Society to implement changes in clinical practice and support affected women.”

When is sodium valproate prescribed?

The drug, used as a mood stabiliser in the treatment of bipolar disorder, and as an anticonvulsant in the treatment of epilepsy, can sometimes be prescribed to pregnant women, with potentially harmful consequences for the foetus. Many of the children born to mothers taking sodium valproate in pregnancy will never live independently. I

n the treatment of bipolar disorder, sodium valproate is not a first line treatment and NICE guidance recommends that sodium valproate should not be offered to women of childbearing age due to the adverse effects on a developing foetus/infant.

Sodium valproate should only be prescribed for women of childbearing potential in exceptional circumstances. In these cases, women must be counselled on the risks of both teratogenicity and adverse neurobehavioural outcomes, they must use effective contraception and the treatment must be reviewed regularly.

The Medicines Healthcare Regulatory Association (MHRA) has developed a Communications Toolkit to aid prescribers in counselling women on the risks of sodium valproate launched in February 2016. A Patient Safety Alert was released by the MHRA in April 2017 calling for all organisations to undertake systematic identification and review of women and girls prescribed sodium valproate.

Are restrictions needed?

Last week, the European Medicines Agency (EMA) hosted the first public hearing to decide whether further restrictions should be placed on sodium valproate prescribing following a second review initiated by the Pharmacovigilance Risk Assessment Committee (PRAC) in March 2017.

The public hearing, hosted by the EMA and PRAC heard evidence from stakeholders including representatives from Bipolar UK, Fetal Anticonvulsant Syndrome Association (FACS), Epilepsy UK, Epilepsy Society, Sanofi and the European Psychiatric Association. Concerns were raised that clear guidance around the prescribing of sodium valproate was not being followed.

The college’s view

It is the view of The Royal College of Psychiatrists that Psychiatrists must work with local pharmacy departments and general practitioners to identify all women of child bearing potential who are prescribed sodium valproate, to ensure that the drug is prescribed only to those women where no other treatment is effective, and to ensure that those women are fully informed of the risks and are using effective contraception.

The RCPsych also supports the proposal to establish a Clinical Expert Panel to collaborate with the EMA to determine whether there is an on-going role for sodium valproate in the treatment of bipolar disorder in women of childbearing age.

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