Monday 22 October 2018

Stronger warnings for child-bearing age women about epilepsy drug

Drug has been linked to birth defects

Pregnant woman and doctor in office
Pregnant woman and doctor in office
Eilish O'Regan

Eilish O'Regan

Strengthened warnings about the prescribing of the medicine valproate, which has been linked to birth defects, were issued to pharmacists today.

The Pharmaceutical Society of Ireland, which regulates pharmacists, said they must inform women of child-bearing age of the potential risk of abnormal pregnancy outcomes when supplying medicines containing valproate.

The drug is used in the management of epilepsy or bipolar disorder.

Pharmacists need to provide counselling and including a leaflet and alert Card with each supply of these medicines.

Niall Byrne, Registrar of the Pharmaceutical Society said: “We cannot overstate the importance of informing patients of the risks associated with medicines containing valproate, which are used in the treatment of epilepsy and bipolar disorder.”

The latest notice to pharmacists regarding sodium valproate (Epilim®²) has been issued following new recommendations from the Pharmacovigilance Risk Assessment Committee this month.

He added: “Patients must be counselled and provided with a Package Leaflet and Alert Card on each occasion these medicines are supplied. Anything less than this is not acceptable. If a member of the public has any concerns they should contact us on valproate.concerns@psi.ie or call 01-2184000.”

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