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New guidance on risks of prescribing valproate for pregnant women

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Updated guidance for nurses and other professionals who prescribe and dispense the epilepsy drug valproate has been published by the medicine regulation body, underlining the risks associated with the drug during pregnancy.

While there have been previous national attempts to ensure female patients are made aware of the risks, there needs to be a further “concerted effort” to ensure professionals are informing all girls and women of a childbearing age, said regulators.

“The actions in this alert ask all organisations to undertake systematic identification of girls and women who are taking valproate”

MHRA and NHS Improvement

A patient safety alert, issued by regulators NHS Improvement and the Medicines and Healthcare products Regulatory Agency, was sent out to healthcare providers yesterday.

It reiterated that the drug – also known as valproic acid – was effective in the treatment of epilepsy and bipolar disorder, but that for all women and girls of a childbearing age, it should only be given by a specialist and after other medicines have proven ineffective.

Unborn babies exposed to valproate during pregnancy are at very high risk (30-40 in every 100) of neurodevelopment disability – such as lower intelligence and autistic spectrum disorders – and also at risk of other birth defects (10 in every 100).

An educational toolkit published by the MHRA has been available since 2015. However, a survey of women in April 2016 found that, among the 624 taking valproate, 20% were not aware of the risks in pregnancy, and around 80% had not received the educational materials.

The toolkit has been updated this month to include guidance on how it can be used by professionals prescribing and dispensing the drug.

It stresses that specialist prescribers should provide female patients with a guide about the drug, ensure they fully understand the risks, and that a checklist has been completed and added to their medical records if treatment is started or continued.

“The actions in this alert ask all organisations to undertake systematic identification of girls and women who are taking valproate, and ensure the MHRA resources are used to support them to make informed choices,” said the regulators.

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