Potential risk of taking valproate when conceiving a child
Valproate-containing medicines (also known as sodium valproate or valproic acid) are approved in Ireland under the brand name Epilim▼ to treat epilepsy and bipolar disorder.
The European Medicines Agency's safety committee (the PRAC) has recommended precautionary measures for valproate use by male patients. This follows the results from a study to assess the risk of neurodevelopmental disorders (NDDs) in children whose fathers were treated with valproate in the three months before conception.
Educational materials for healthcare professionals and patients
Further information on the safe and effective use of valproate in male patients is provided in the following educational material for healthcare professionals and patients:
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A patient guide for male patients, which the prescriber should give to all male patients who begin treatment with valproate or are already undergoing treatment.
- A patient card, attached to the packaging of valproate to facilitate discussions between the pharmacist and the patient each time valproate is dispensed.
More information regarding the use of valproate is also available in the approved product information, which contains the Summary of Product Characteristics (SmPC) for healthcare professionals and the Package Leaflet (PL) for patients.
Do not stop taking your medication before speaking to your doctor
Patients should not stop taking valproate without consulting a doctor.
Male patients who have been prescribed valproate must not stop taking their medicine without consulting their doctor. Sudden discontinuation of any treatment for epilepsy should be avoided as this may lead to seizures that could have serious consequences for the patient.
Reporting suspected side effects to the HPRA
Valproate–containing medicines are subject to additional monitoring requirements. Any medicine subject to additional monitoring in the EU is identifiable by an inverted black triangle after the medicine's name ▼. Healthcare professionals and members of the public are requested to report any suspected adverse reactions associated with their use via the HPRA reporting forms.