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Health Sciences Authority
Dear Healthcare Professional Letters

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

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

7 November 2024

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

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.

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.

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