TOPAMAX® (Topiramate) TABLETS 25mg, 50mg and 100mg: Risk of neurodevelopmental disorders (autism spectrum disorder and intellectual disability) in children following in utero exposure and reminder on use of topiramate during pregnancy

A Dear Healthcare Professional Letter has been issued by Johnson & Johnson International (Singapore) Pte Ltd to inform healthcare professionals of new safety updates regarding an increased risk of neurodevelopmental disorders (autism spectrum disorder and intellectual disability) in children exposed to topiramate in utero, as well as to remind about the existing risks of congenital abnormalities related to the use of topiramate during pregnancy. Revisions to the Singapore package inserts for TOPAMAX® are being made, including the recommendation of highly effective contraception in women of childbearing potential before treatment initiation and informing patients of the risk related to the use of topiramate during pregnancy. Please refer to the letter for details.
Healthcare professional, Industry member, Therapeutic Products
Published:

Dear Healthcare Professional Letters

6 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.