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The Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licence for valproate (also known as Epilim and Depakote), a treatment for bipolar disorder. Valproate must no longer be prescribed to women or girls who could become pregnant, unless they are on the pregnancy prevention programme.
Children born to women who take valproate during pregnancy are at significant risk of birth defects and developmental disorders. Healthcare professionals wanting to prescribe valproate to women of childbearing age must make sure they are enrolled in the pregnancy prevention programme, which is designed to make sure women are fully aware of the risks and are using contraception.
All women and girls who are prescribed valproate should contact their GP to have their treatment reviewed. No one should stop taking valproate without medical advice.
Why are changes being made?
For many years, there have been warnings that taking valproate while you are pregnant increases the risks of your child being born with birth defects. More recent research also suggests that it can lead to developmental disorders for your child. The latest European review suggested more needs to be done to prevent harm to babies and to raise awareness of the risks of talking valproate.
What do the changes mean for me?
If you are currently taking valproate and are able to become pregnant, it is important that you speak to your GP about how the changes may affect you.
Hearing about the risks caused by medication that you’re taking can be worrying, especially if you have never been told about them before. It is important to speak to your GP and not to stop taking valproate suddenly as this can be very dangerous.
You can find out more on our pages about valproate.