Key Safety Update
The MHRA has issued a precautionary safety alert regarding valproate use in men. A retrospective observational study has identified a possible association between valproate use by men around the time of conception and an increased risk of neurodevelopmental disorders in their children.
What You Need to Know
- The alert applies to male patients taking valproate who are planning to father children or whose partners may become pregnant
- The risk is based on paternal exposure at or around the time of conception
- This is a precautionary measure pending further evidence
Recommended Actions
Healthcare professionals should:
- Inform male patients taking valproate of this potential risk
- Advise men and their partners to use effective contraception as a precaution
- Review the necessity of valproate therapy in men of reproductive age
- Document discussions and advice given in patient records
Affected Medications
All valproate-containing products are included in this alert, including:
- Sodium valproate
- Valproic acid
- Divalproex sodium
- Modified-release formulations
Further Information
For the full MHRA drug safety update, visit the official MHRA alert page.