Sodium Valproate resources and information

Supplying valproate safely

Children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders and at an increased risk of lower birth weight. There is a potential small increased risk of harm to children if valproate is used by a father at conception. Men taking valproate are at an increased risk of impaired fertility. As such, it is vital that valproate is dispensed and supplied safely. 
 

Drug Safety Update and updated safety and educational materials

In June 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) published a Drug Safety Update and updated safety and educational materials to support healthcare professionals and patients to implement the existing regulatory requirements. 

The updates reflect:

  • precautionary advice on the potential risk of neurodevelopmental disorders in children fathered by men taking valproate around the time of conception
  • a risk of lower weight at birth for the gestational age in children exposed to valproate during pregnancy

Updated safety and educational materials 

The following new or updated safety and educational materials are now available on the MHRA website: 

Annual Risk Acknowledgement Form for female patients

Risk Acknowledgement Form for male patients starting valproate

Patient guide for women

Patient guide for men

Patient card

Booklet for healthcare professionals

Valproate dispensary poster
 

Updated Drug Safety Update and infographics

In February 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) published an updated Drug Safety Update. This states that the requirement for a review by two specialists remains in place for patients initiating valproate under 55 years of age, but the Commission on Human Medicines have advised that it will not be required for men (or males) currently taking valproate.

The MHRA have produced three infographics to clarify in which situations review by two specialists may be required: 

A list of who might qualify as a specialist can be found at valproate safety measures.

Supplying valproate safely

Pharmacy teams have a key role in dispensing and supplying valproate safely. 

  • valproate must not be used in any woman or girl able to have children unless there is a pregnancy prevention programme (PPP) in place.
  • valproate must always be dispensed in the manufacturer’s original full pack unless there are exceptional circumstances.
  • valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.
  • At their next annual specialist review, women of childbearing potential and girls should be reviewed using a revised valproate Risk Acknowledgement Form, which will include the need for a second specialist signature if the patient is to continue with valproate and subsequent annual reviews with one specialist unless the patient’s situation changes.

Full pack dispensing 

What you need to know

  • Unless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack.
  • Pharmacy teams must either round up or down so that the patient receives their supply in the manufacturer’s original full pack and ensure that they receive an amount that is as close as possible to that prescribed.
  • Valproate-containing medicines must not subsequently be re-packaged into plain dispensing packaging.

Exceptional circumstances 

The manufacturer’s original full pack does not have to be supplied where: 

  • a risk assessment is in place that refers to the need for the patient to be sold or supplied valproate-containing medicines in different packaging from its manufacturer’s original full outer packaging (for example, in a monitored dosage system) and
  • assuming that the product is authorised, there are processes in place to make sure that the patient receives the patient information leaflet. That is not the case for unauthorised medicines, unless they are only unauthorised as a result of an assembly process.

Further information is available on the MHRA website.

More information and resources 

Read a case study about discussing the risks and benefits of taking valproate with a patient who’s been prescribed it for several years. We've developed this case study with the General Medical Council and the Nursing and Midwifery Council. 

Watch our film where we speak to two women whose children were affected by exposure to sodium valproate during their pregnancies, to find out why it’s so important to make sure that women are made aware of the risks when dispensing and supplying valproate.

Find out more in this example of notable practice on supporting people taking valproate from our Knowledge Hub. 

Watch this video created by Central & North West London NHS Trust, in which a pharmacist talks to a patient about the risks of valproate which explains the Pregnancy Prevention Programme.

NHS Wales Valproate Information Hub

Hyb gwybodaeth sodiwm falproad