Sodium valproate (Epilim) use in people who can father children: important new safety information
Medsafe is highlighting new information that suggests a potential increased risk of neurodevelopmental disorders in children whose fathers were treated with sodium valproate (Epilim) at the time of the child’s conception.
Advice for consumers
- Keep taking your Epilim/sodium valproate as prescribed by your doctor.
- If you father a child while taking Epilim/sodium valproate, it is possible the child may have impaired mental and/or motor development problems.
- Use effective contraception if you are starting or continuing on Epilim/sodium valproate treatment
- If you are able to father children, speak with your doctor about the potential risks of taking Epilim/sodium valproate during conception, and your options if you wish to start a family.
Information for healthcare professionals
- The Epilim data sheet and CMI have been updated to include new safety information relating to use in males of reproductive potential.
- Use of sodium valproate at the time of conception by people who are able to father children has been linked to a potential increased risk of neurodevelopmental disorders in children compared to those who took lamotrigine/levetiracetam.
- Inform patients of this potential risk and consider alternative treatment options for those wishing to father a child.
- Discuss the need for effective contraception when starting sodium valproate and periodically throughout treatment.
- The company has produced a guide which should be provided to all male patients of reproductive potential using sodium valproate.
Read the alert communication for more information.