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MHRA reviews into safe use of valproate

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The Medicines and Healthcare products Regulatory Agency (MHRA) has advised ‘no one should stop taking valproate without advice from their healthcare professional.’

The latest data on the use of valproate in England revealed that in the last 6 months the number of pregnant women prescribed valproate in a 6-month period has fallen from 68 women in April to September 2018, to 17 women in October 2021 to March 2022.

In light of concerns that the current regulatory requirements for safe use are not being consistently followed, the MHRA conducted a review of the available data and asked for advice from the independent Commission on Human Medicines (CHM).

“The CHM has advised that no one under the age of 55 should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment,” said MHRA.

“Where possible, existing patients should be switched to another treatment unless two specialists independently consider and document that there is no other effective or tolerated treatment or the risks do not apply.”

The CHM has established an implementation group to support the safe introduction of the new measures into clinical practice over the coming months. The implementation group includes representation from across the healthcare system and has advised that the measures should be introduced in patient care through a phased programme currently under development according to patient safety priorities, in collaboration with the healthcare bodies to ensure ongoing patient care is not disrupted. No action is currently needed from patients.

MHRA has urged healthcare professionals to consider alternative options before initiating valproate and to continue to adhere closely to the Pregnancy Prevention Programme in girls and women of child-bearing potential who are taking valproate.

“No one should stop taking valproate without advice from their healthcare professional.”

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