The iHV was pleased to have contributed to this important guidance produced by the Medicines and Healthcare products Regulatory Agency (MHRA) on the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
Valproate is prescribed for some patients with epilepsy or bipolar disorder.
Key messages:
- Valproate should only be prescribed to patients (male or female) aged under 55 years when two specialists have agreed that your condition does not respond to other treatments and the benefits of treatment outweigh the risks.
- No one should stop taking valproate without advice from a specialist because of the importance of keeping their condition well managed.
Information for female patients: Valproate must not be prescribed to any woman or girl able to have children unless the conditions of the Pregnancy Prevention Programme (PPP) are followed.
The risks of women taking valproate during pregnancy: In women who take valproate while pregnant, around 1 in 9 babies (11%) will have a birth defect. About 3 or 4 children in every 10 may have problems with early childhood development. These disorders can be seriously debilitating and permanent.
Information for men: All male patients should be made aware of the risks and benefits of being prescribed valproate. Male patients aged under 55 years being started on valproate are required to complete a Risk Acknowledgement Form with a healthcare professional. Valproate can potentially cause:
- Male infertility (which may be reversible after treatment is stopped or the dose is reduced in some patients).
- Toxic effects on the testes; it is currently unclear what this means for humans.
- The risks of men taking valproate around the time of conception: In men who take valproate in the 3 months before conception, about 5 children in every 100 may have neurodevelopmental conditions (problems with early childhood development). Due to limitations in the data, it is not clear if the increased risk for neurodevelopmental conditions is caused by valproate or other factors. Unfortunately, there is not enough data to show which particular type of disorder children may be at risk of developing.
Current advice: If you are taking valproate, do not stop without first discussing it with your specialist. If you are taking valproate and you are planning a family, contact your doctor so you can talk through your options.
Valproate-containing medicines include sodium valproate, valproic acid and valproate semisodium, so you may see these names on the box. Products may also be referred to using various brand names which include Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell.