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:
Dr Diarmuid Quinlan
Medical Director