Skip to main content
A Singapore Government Agency Website How to identify
Official website links end with .gov.sg
Government agencies communicate via .gov.sg websites (e.g. go.gov.sg/open). Trusted websites
Secure websites use HTTPS
Look for a lock () or https:// as an added precaution. Share sensitive information only on official, secure websites.

Government officials will never ask you to transfer money or disclose bank log-in details over a phone call.

Call the 24/7 ScamShield Helpline at 1799 if you are unsure if something is a scam.

Health Sciences Authority
Dear Healthcare Professional Letters

Epilim® (valproate) - Risk of congenital malformations and serious developmental disorders in children exposed in utero to valproate

Audiences

Healthcare professional

Product type

Therapeutic Products

15 March 2018

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

Sanofi-Aventis has issued an annual reminder to inform healthcare professionals of the risk of congenital malformations and serious developmental disorders in children who are exposed in utero to Epilim®. As children exposed in utero to valproate are at a high risk of serious developmental disorders and/or congenital malformations, valproate should not be prescribed to female children, female adolescents, women of child-bearing 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 urgently when a woman plans a pregnancy or becomes pregnant. Female patients must be informed of and understand the risks associated with valproate during pregnancy, the need to use effective contraception and for regular review of treatment, and to rapidly inform the physician if she is planning a pregnancy or becomes pregnant. The local package insert has been updated with warnings on risks of valproate use 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.

Back to top