The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended strengthening the restrictions on the use of valproate medicines due to an increased risk of birth defects and developmental problems in children exposed to valproate in the womb.
It is being recommended that valproate medicines should not be used to treat epilepsy and bipolar disorder in girls, women who can become pregnant or pregnant women unless other treatments are ineffective or not tolerated.
The recommendations will now be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for a final opinion.
We will provide further information to patients and healthcare professionals once a final opinion is reached.
Dr. Sarah Branch, Deputy Director of MHRA’s Vigilance and Risk Management of Medicines division said:
“There are already strong warnings contained in product information for patients and prescribers on the potential for birth defects and developmental disorders in children born to women taking valproate during pregnancy. It is now being recommended that this information is strengthened further.
“It is important that anyone taking valproate should not stop their treatment without first discussing it with their doctor.
“If anyone has any questions they should speak with their GP or pharmacist.”