Correspondence from Dr Colm Henry, HSE Chief Clinical Officer

Please see the attached correspondence from Dr Colm Henry, HSE Chief Clinical Officer and the related HPRA alert.

In brief:

• There may be an increased risk of neurodevelopmental disorders in children conceived to men treated with valproate (Epilim®) in the three months leading up to conception
• The European Medicines Agency recommends that valproate use in males should be initiated and supervised by a specialist experienced in its use in bipolar affective disorder or epilepsy
• The potential risks should be explained to men prescribed valproate (Epilim®)
• Mitigation measures should be advised (consider alternative agents, reliable contraception, avoidance of sperm donation)

Correspondence:

• Correspondence from CCO to GPs (PDF, 436KB)
• HPRA Notification Valproate New Precautionary Measures in Men (PDF, 162KB)

Dr Diarmuid Quinlan
Medical Director