TOPAMAX® (topiramate) – Safety measures to prevent exposure during pregnancy

A Dear Healthcare Professional Letter has been issued by Johnson & Johnson International (Singapore) Pte Ltd to inform healthcare professionals of the safety measures developed for TOPAMAX® (topiramate) to prevent its exposure during pregnancy. Topiramate can cause major congenital malformations and foetal growth restriction when used during pregnancy, and recent data also suggests a possible increased risk of neurodevelopmental disorders in children of mothers exposed to topiramate during pregnancy. Topiramate for prophylaxis of migraine is already contraindicated in pregnancy and in women of childbearing potential who do not use a highly effective method of contraception. Safety measures include performing pregnancy testing and use of a highly effective contraceptive method prior to initiating topiramate in women of childbearing potential, and informing patients of the risk of topiramate use during pregnancy. Treatment with topiramate should also be reassessed periodically to confirm if the pregnancy prevention measures are adhered to. Healthcare professionals are advised to weigh the benefits of topiramate therapy against the risks and consider alternative therapeutic options when treating women of childbearing potential. Educational materials for healthcare professionals and patients have been developed by Johnson & Johnson. Please refer to the letter for details.
Healthcare professional, Industry member, Therapeutic Products
Published:

Dear Healthcare Professional Letters

7 Nov 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.