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.

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 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.