Precautionary measures for male patients using valproate-containing medicines

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 in 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.

Further information is available through the links below:

  • 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.
Valproate (Epilim) Guide for Male Patients PDF : 169 KB | 08/01/2025
  • A guide for healthcare professional guide (see section for ‘Male Patients’) potentially involved in the care of male patients treated with valproate.
Valproate (Epilim) Guide for Healthcare Professionals PDF : 635 KB | 08/01/2025
  • A patient card, attached to the packaging of valproate to facilitate discussions between the pharmacist and the patient each time valproate is dispensed.
Valproate (Epilim) Patient Card PDF : 61 KB | 08/01/2025
  • Direct Healthcare Professional letter February 2024
Direct Healthcare Professional letter – February 2024 PDF : 372 KB | 08/01/2025

    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.

    HPRA approved communications for healthcare professionals

    2024

    Drug Safety Newsletter Edition 116 - September 2024 PDF : 317 KB | 28/02/2025 Valproate EdM Distribution Letter June 2024 PDF : 408 KB | 31/05/2024 Drug Safety Newsletter Issue 115 April 2024 PDF : 280 KB | 25/04/2024 Valproate DHPC Feb 2024 PDF : 371 KB | 19/02/2024

    2023

    Drug Safety Newsletter Issue 113 Nov 2023 PDF : 628 KB | 03/11/2023

    Ongoing review of potential risk of neurodevelopmental disorders in children of fathers treated with valproate in the three months prior to conception.

         Valproate DHPC Sept 2023 PDF : 409 KB | 14/09/2023

    Additional resources