Published: 7 December 2023
Safety Information
Alert communication
Sodium valproate (Epilim) use in people who can father children: important new safety information
30 May 2023
A retrospective observational study suggests a potential increased risk of neurodevelopmental disorders in children whose fathers were treated with Epilim at the time of the child’s conception compared to those treated with lamotrigine or levetiracetam.
Epilim is the brand name for sodium valproate containing medicines in New Zealand.
The Epilim data sheets and consumer medicine information (CMI) leaflets have been updated with this important safety information. A Dear Healthcare Professional Letter (DCHP) (pdf, 2 pages, 157 KB) has also been produced.
- Advice for consumers and caregivers
- Information for healthcare professionals
- Further information
- Useful links
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.
Products affected
Epilim (sodium valproate) is indicated for the treatment of epilepsy and bipolar disorder.1
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics is the New Zealand sponsor on behalf of Sanofi for all Epilim products in New Zealand.
| Product name | Strength |
|---|---|
| Epilim EC modified release tablet | 200 mg, 500 mg |
| Epilim Liquid oral solution | 200 mg/ 5 mL |
| Epilim 100 crushable tablet | 100 mg |
| Epilim IV Powder for injection with diluent | 100 mg/mL |
| Epilim Syrup | 200 mg/5mL |
Further information
A retrospective observational study of electronic medical records in 3 European Nordic countries suggested a potential increased risk of neurodevelopmental disorders in children after paternal exposure to sodium valproate compared to those treated with lamotrigine or levetiracetam.
The study evaluated the association between paternal exposure to different anti-epileptic drugs at the time of conception and the risk of neurodevelopmental disorders.
The study identified a potential increased risk of neurodevelopment disorders in children (from 0 to 11 years old) born to males treated with sodium valproate at the time of conception, compared to those treated with lamotrigine or levetiracetam.
Across the 3 countries, the adjusted cumulative risk of neurodevelopmental disorders ranged from 5.6% to 6.3% in the sodium valproate group versus 2.5% to 3.6% in the composite lamotrigine/levetiracetam monotherapy exposure. The pooled adjusted hazard ratio for neurodevelopmental disorders overall, obtained from the meta-analysis of the 3 datasets, was 1.47 (95% CI: 1.10–1.96). As a reminder, it is estimated that up to 30-40% of children whose mothers took valproate during pregnancy may have problems with early childhood development.
Due to study limitations, it was not possible to determine which of the studied neurodevelopmental subtypes (autism spectrum disorder, intellectual disability, communication disorder, attention deficit/hyperactivity disorder, movement disorders) contributed to the overall increased risk of neurodevelopmental disorders. Further investigations are needed.
Useful links
Consumers and caregivers:
- Sodium valproate male patient guide (Sanofi) (pdf, 2 pages 210 KB)
- Epilim/sodium valproate consumer medicines information (oral formulations) (pdf, 10 pages, 142 KB)
- Epilim/sodium valproate consumer medicines information (injection) (pdf, 9 pages, 241 KB)
- Report an adverse reaction to a medicine
Health professionals:
- Dear healthcare professional letter (DHCP) (pdf, 2 pages, 157 KB)
- Sodium valproate educational materials for healthcare professionals (updated) (Sanofi)
- Sodium valproate male patient guide (Sanofi)
- Epilim/sodium valproate data sheet (oral formulation) (pdf 45 pages, 324 KB)
- Epilim/sodium valproate data sheet (injection) pdf 43 pages 536 KB)
- Report an adverse reaction to a medicine
References
- Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics. 2022. Epilim New Zealand data sheet 15 September 2022. URL:medsafe.govt.nz/profs/Datasheet/e/Epilimtabsyrliqiv.pdf (accessed 11 May 2023)
