UK Wedding News
25/04/2018
The MHRA has changed the licence for valproate medicines (Epilim, Depakote and generic brands) used to treat epilepsy and bipolar disorder.
The MHRA has warned that children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders, with up to four in 10 babies are at risk of developmental disorders and approximately one in 10 are at risk of birth defects if valproate is taken during pregnancy.
All women and girls who are prescribed valproate should contact their GP and arrange to have their treatment reviewed. No woman or girl should stop taking valproate without medical advice.
A letter will be sent to all relevant healthcare professionals in the coming weeks outlining the new requirements and providing updated educational materials. NICE is also amending its guidelines where valproate is mentioned, to reflect the new regulatory position.
It is hoped that these measures, used across health sectors, will help reduce the number of pregnancies exposed to valproate medicines and will make sure all women and girls of childbearing potential are aware of the risks.
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Valproate Not To Be Used While Pregnant
Epilepsy drug valproate must no longer be prescribed to women or girls of childbearing age unless they are on the pregnancy prevention programme (PPP), according to the Medicines and Healthcare products Regulatory Agency (MHRA)The MHRA has changed the licence for valproate medicines (Epilim, Depakote and generic brands) used to treat epilepsy and bipolar disorder.
The MHRA has warned that children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders, with up to four in 10 babies are at risk of developmental disorders and approximately one in 10 are at risk of birth defects if valproate is taken during pregnancy.
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All women and girls who are prescribed valproate should contact their GP and arrange to have their treatment reviewed. No woman or girl should stop taking valproate without medical advice.
A letter will be sent to all relevant healthcare professionals in the coming weeks outlining the new requirements and providing updated educational materials. NICE is also amending its guidelines where valproate is mentioned, to reflect the new regulatory position.
It is hoped that these measures, used across health sectors, will help reduce the number of pregnancies exposed to valproate medicines and will make sure all women and girls of childbearing potential are aware of the risks.
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