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Health Sciences Authority
Dear Healthcare Professional Letters

Epilim® (Valproate) - Risk of neurodevelopmental disorders including autism spectrum disorders in children after paternal exposure

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

20 March 2023

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by Sanofi-Aventis Singapore Pte. Ltd. to inform healthcare professionals of new safety information regarding a higher risk of neurodevelopmental disorders (NDDs), including autism spectrum disorders, in children after paternal exposure to valproate as compared to lamotrigine or levetiracetam. This finding was from a retrospective observational study on electronic medical records in 3 European Nordic countries where there was an increased risk of NDDs in children (0 to 11 years old) born to men treated with valproate at the time of conception compared to those treated with lamotrigine/levetiracetam. The Singapore package insert for Epilim® (valproate) is being revised. There are also revised and new educational materials for healthcare professionals and patients. Healthcare professionals are advised to inform male patients of this potential risk and consider alternative therapeutic options with the patients. In men initiating or remaining on valproate treatment, it is recommended for healthcare professionals to discuss with the patient, at least annually, the need for effective contraception, and to ensure that the male patient has acknowledged the risk and precautions associated with valproate use. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg (opens in new tab) and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.