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
"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
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
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
Telephone: 0203 701
Out-of-hours contact number: 07860