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Health Sciences Authority
Dear Healthcare Professional Letters

Epilim® (Valproate) – Updates and new measures relating to the risk of neurodevelopmental disorders in children of fathers treated with valproate

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

23 January 2024

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. as a follow-up to their earlier communication in March 2023 to update on the potential risk of neurodevelopmental disorders (NDDs) in children of fathers treated with valproate in the 3 months prior to conception compared to those treated with lamotrigine or levetiracetam, as well as the new measures introduced to address this risk. The adjusted cumulative risk of NDDs and pooled adjusted hazard ratio have been revised based on further analysis of previously published study results. In addition to informing male patients of the potential risk of NDDs in children of fathers treated with valproate in the 3 months prior to conception, prescribers are advised to discuss with male patients on alternative therapeutic options, the need for effective contraception while using valproate and for 3 months after stopping treatment and the need for regular (at least annual) review of treatment. The Singapore package insert for Epilim® (Valproate) has been updated to reflect these recommendations, and the updated educational materials will be disseminated to healthcare professionals when available. 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.