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New advice for males on valproate

Earlier this year we shared that the Medicines and Healthcare products Regulatory Agency (MHRA) changed their advice for all males taking valproate. They advised that:

“Male patients on valproate who are planning a family in the next year should talk to their healthcare professional about their treatment.”

The MHRA have updated their guidance and now advise:

“Male patients on valproate to use contraception.”

The update is linked to research about the outcomes in children whose fathers took valproate at the time of conception. The study suggests that if you father a child while you are taking valproate or in the 3 months after stopping valproate, there may be a small increased risk of the child having a neurodevelopmental disorder.

After reviewing the study results, the MHRA have decided to update their guidance.

New advice for boys and men on valproate:

  • Do not stop taking valproate unless your specialist advises you to because of the need to keep your condition under control. 
  • Use condoms while on valproate and for 3 months after stopping.
  • Ask your female sexual partner to also use birth control to prevent them from becoming pregnant.
  • Go to your next appointment to talk about the risks and your options when invited.
  • Let your doctor know if you are planning to father a child and you are on valproate.
  • Do not donate sperm while on valproate or for 3 months after stopping valproate.
  • Report any harmful reactions you may have linked with valproate on a Yellow Card.

For more information and advice on valproate please see MHRA’s valproate safety measures.

Please do not stop taking valproate without advice from your healthcare professional. If you are worried about the risks of valproate, talk to your doctor, nurse, pharmacist or another healthcare professional.