ISSUE 2 APRIL
Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 7 March 2025.
Summary
A retrospective observational study in Europe has suggested there may be an increased risk of neurodevelopmental disorders in children born to men* who had been taking sodium valproate in the 3 months before conception compared to children born to men treated with lamotrigine or levetiracetam.1
Neurodevelopmental disorders studied included autism spectrum disorder, intellectual disability, communication disorder and attention deficit/hyperactivity disorder, and movement disorders.
Due to methodological limitations, the findings of this study should be interpreted with caution.
As a precaution, Sanofi-Aventis, the sponsor of Epilim, which is the original brand of sodium valproate, have added new warnings about paternal exposure to the Product Information (PI) and Consumer Medicine Information (CMI). Sponsors of generic sodium valproate products will be required to align their safety information with Epilim.
What health professionals should do
The new warnings instruct health professionals to inform their male patients about the potential risks of sodium valproate and discuss the need for effective contraception, for both the patient and their female partner.
Male patients taking sodium valproate should be specifically advised:
- to consult their doctor to discuss alternative treatment options if they are planning to father a child, and before discontinuing contraception
- to contact their doctor for counselling if pregnancy occurs and they have taken sodium valproate in the 3 months prior to conception
- not to donate sperm during, and for 3 months after stopping, sodium valproate treatment.
Men taking sodium valproate should be reviewed regularly (at least annually) by a specialist experienced in the management of epilepsy or bipolar disorder to consider whether valproate-containing medicine remains the most suitable option, particularly when the patient is planning to conceive a child.
Existing recommendations in the PI about maternal exposure to sodium valproate remain unchanged as we [the TGA] continue routine safety monitoring and surveillance of this medicine. Patients with childbearing potential and taking sodium valproate are encouraged to discuss any concerns with a health professional.
*The TGA follows 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 human reproduction, in a medical context. These concepts are difficult to express with the accuracy needed using the inclusive language currently available. This update also contains excerpts of material produced by the sponsor, which we cannot control.
See the full article on the TGA website.
