Sodium valproate belongs to a group of medicines called anticonvulsants. It is used to treat epilepsy and mania. In Australia, sodium valproate is sold as Epilim and is also available as 5 generic brands. We will call this medicine valproate in this safety alert.
It is well known that valproate can cause malformations and neurodevelopmental disorders in babies born to women* taking valproate before and during pregnancy. Because of this, women and people who can give birth to children are advised to avoid taking this medicine at those times.
A recent European study has now suggested that there may also be an increased risk of neurodevelopmental disorders in children where the man involved* in the conception has been taking valproate in the 3 months before the pregnancy happened.
There is no proof that valproate causes these problems in a child who was conceived when the man was taking the medicine, and there have been no reports of this happening in Australia. But to be safe, the company that makes Epilim has added new warnings about this possible risk to their Product Information and Consumer Medicine Information. The companies that supply the other brands of valproate in Australia will also be adding these warnings to their product and consumer medicine information.
What are neurodevelopmental disorders?
Neurodevelopmental disorders affect how the nervous system develops, which includes the brain and spinal cord. These conditions include autism spectrum disorder, intellectual disability, communication disorder, attention deficit hyperactivity disorder (ADHD) and movement disorders.
They can affect how a child will learn, communicate, move and interact with their world.
Please note that at this time, there is no strong evidence that valproate causes these problems in a child if taken by the man involved in their conception. This alert is warning you of the possibility.
What patients should do
Men taking valproate should not stop their treatment without talking to their doctor.
The doctor will talk to you about:
- the possible risks when fathering a child
- using contraception (birth control) during treatment and for 3 months after stopping valproate, which a female partner should also be doing
- consulting a doctor about other treatment options as soon as you plan to father a child and before stopping contraception (birth control)
- not donating sperm during treatment with valproate and for 3 months after stopping treatment.
What health professionals should do
Read the details of the study and the new warnings in the Medicine Safety Update article: Potential risk of neurodevelopmental disorders in children born to men taking sodium valproate.
Please note that existing recommendations in the Product Information about maternal exposure to valproate remain unchanged.
We continue routine safety monitoring and surveillance of this medicine.
*Please note that we follow a policy to use inclusive language according to the Australian Government Style Manual, including language that respects gender and sexual diversity. This update contains references to the sex characteristics of people, and the relationships that may be involved in conceiving a baby, in a medical context. It is difficult to talk about medical concepts such as these accurately using the inclusive language available to us currently.