The Medicines & Healthcare products Regulatory Agency (MHRA) has issued a new safety alert regarding the anti-seizure drug valproate.
Men taking this medication are now advised to inform their doctor if they are planning to father a child.
Study Findings
A recent study of health records has revealed a small increase in the risk of neurodevelopmental disorders in children whose fathers were taking valproate at the time of conception. The study found:
- Approximately 5 in 100 children whose fathers were taking valproate at conception had a developmental disorder.
- In comparison, only about 3 in 100 children were affected when their fathers were taking other anti-seizure medications such as lamotrigine or levetiracetam.
Whilst the study doesn’t prove that valproate use in men increased the risk of problems in children, the MHRA considers the increased risk a safety concern that warrants action on a precautionary basis.
New Advice for Male Patients
In light of these findings, the MHRA has issued the following guidance for men taking valproate:
- Continue taking valproate unless advised otherwise by a specialist, to maintain control of your condition.
- Use condoms while on valproate and for three months after stopping treatment. Female partners should also use birth control.
- Attend scheduled appointments to discuss risks and options.
- Inform your doctor if you are planning to father a child while on valproate.
- Refrain from donating sperm while on valproate and for three months after stopping treatment.
Important Reminders
The MHRA emphasises that patients should not stop taking valproate or change their dosage without consulting a specialist. This precaution is crucial to prevent potential health complications related to their condition.
Patients are urged to speak to their GP or specialist if they have any queries or concerns about this issue.
For more detailed information on this safety alert and its implications, visit the MHRA’s official website.
