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Health Sciences Authority
Dear Healthcare Professional Letters

Risk of congenital malformations and serious developmental disorders in children exposed in utero to valproate

15 February 2016

Audiences

Healthcare professional

Product-type

Therapeutic Products

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

Sanofi-Aventis would like to inform healthcare professionals of the risk of congenital malformations and serious developmental disorders in children exposed in utero to Epilim® (sodium valproate, valproic acid). Children exposed in utero to valproate are at a high risk of serious developmental disorders and/or congenital malformations. Hence, valproate should not be prescribed to female children, female adolescents, women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated. Valproate treatment must be started and supervised by a specialist experienced in managing epilepsy or bipolar disorder. Healthcare professionals are advised to carefully balance the benefits of valproate treatment against the risks when prescribing valproate for the first time, at routine treatment reviews, when a female child reaches puberty and when a woman plans a pregnancy or becomes pregnant. They are also advised to ensure that all female patients are informed of and understand the risks associated with valproate during pregnancy; the need for  effective contraception and regular treatment review as well as the need to rapidly consult her physician if she is planning a pregnancy or becomes pregnant. The local package inserts for Epilim® products have been strengthened on the warnings on valproate use in pregnancy.Please refer to the letter for more information.

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 (opens in new tab) 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.