October 4 2017: The RCPsych welcomes the
Pharmacovigilance Risk Assessment Committee (PRAC) review into the
use of sodium valporate for pregnant women, announced last
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
In 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
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
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.
For further information, please
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