Alert Communication: Sodium valproate (Epilim) use in people who can father children

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.