Other safety alerts

Singapore: Epilim® (valproate): Risk of neurodevelopmental disorders including autism spectrum disorders in children after paternal exposure

Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Sanofi-Aventis Singapore Pte. Ltd. to inform healthcare professionals of new safety information regarding a higher risk of neurodevelopmental disorders (NDDs), including autism spectrum disorders, in children after paternal exposure to valproate as compared to lamotrigine or levetiracetam.

This finding was from a retrospective observational study on electronic medical records in 3 European Nordic countries where there was an increased risk of NDDs in children (0 to 11 years old) born to men treated with valproate at the time of conception compared to those treated with lamotrigine or levetiracetam.

The Singapore package insert for Epilim® (valproate) is being revised. There are also revised and new educational materials for healthcare professionals and patients. Healthcare professionals are advised to inform male patients of this potential risk and consider alternative therapeutic options with the patients. In men initiating or remaining on valproate treatment, it is recommended for healthcare professionals to discuss with the patient, at least annually, the need for effective contraception, and to ensure that the male patient has acknowledged the risk and precautions associated with valproate use.

Please refer to the following website in HSA for details: http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/epilim-(valproate)---risk-of-neurodevelopmental-disorders-including-autism-spectrum-disorders-in-children-after-paternal-exposure

In Hong Kong, there are 10 registered pharmaceutical products containing valproate. All products are prescription-only medicines. So far, the Department of Health (DH) has received 14 cases of adverse drug reaction related to valproate, but these cases were not related to the risk of NDDs in children after paternal exposure to valproate. In light of the above HSA’s announcement, letters to inform local healthcare professionals will be issued. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.

Ends/Wednesday, Mar 22, 2023
Issued at HKT 15:00

Related Information:

European Union: PRAC assessing new data on potential risk of neurodevelopmental ... Posted 2025-07-12

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronos... Posted 2025-06-11

The United Kingdom: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epil... Posted 2025-06-11

Australia: Potential risk of neurodevelopmental disorders in children born to me... Posted 2025-03-07

The United Kingdom: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epil... Posted 2025-02-14

The United Kingdom: Valproate use in men: as a precaution, men and their partner... Posted 2024-09-06

European Union: Precautionary measures to address potential risk of neurodevelop... Posted 2024-01-27

Singapore: Epilim® (valproate): Updates and new measures relating to the risk of... Posted 2024-01-24

European Union: Potential risk of neurodevelopmental disorders in children born ... Posted 2024-01-13

The United Kingdom: Valproate: re-analysis of study on risks in children of men ... Posted 2023-08-31

European Union: EMA review of data on paternal exposure to valproate Posted 2023-08-17

The United Kingdom: Safety of valproate – new study on risks in children of men ... Posted 2023-08-17

Epilim® (valproate) - Risk of neurodevelopmental disorders including autism spec... Posted 2023-03-22