MHRA Alert – Valproate Use in Men and Contraception Advice

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.