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

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.
Healthcare professional, Industry member, Therapeutic Products
Published:

Dear Healthcare Professional Letters

21 Mar 2023

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.