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

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.
Healthcare professional, Industry member, Therapeutic Products
Published:

Dear Healthcare Professional Letters

23 Jan 2024

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

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.