Other safety alerts

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

Health Sciences Authority (HSA) announces that 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 following website in HSA for details: http://www.hsa.gov.sg/content/hsa/../epilim-valproateriskofcongenitalmalformationsandseriousdevelopme.html

In Hong Kong, there are 12 registered pharmaceutical products containing valproic acid and/or valproate, and all products are prescription-only medicines. So far, the Department of Health (DH) has received 8 cases of adverse drug reaction in connection with valproic acid or valproate, but none of them was related to adverse effects in new-born babies whose mothers took valproate for their medical conditions.

In Dec 2014, the Registration Committee of the Pharmacy and Poisons Board discussed the findings of an European Medicines Agency’s (EMA) previous review on the risks of valproate products in pregnancy and had decided that warnings and precautions on the risks of pregnancy should be included in valporate products. As previously reported, an EMA’s recent review started in 2017, which recommends further restrictions and measures to avoid valproate exposure in pregnancy, is currently pending adoption. DH will remain vigilant on the development of the issue and safety update of the drug issued by other overseas drug regulatory authorities.

Ends/Friday, Mar 16, 2018
Issued at HKT 16:00

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: MHRA instructs health organisations to prepare now for new m... Posted 2023-11-30

The United Kingdom: Valproate: reminder of current Pregnancy Prevention Programm... Posted 2022-12-13

Valproate: MHRA's reminder of current Pregnancy Prevention Programme requirement... Posted 2022-12-13

台灣：公告修訂含valproate類成分藥品用於婦女的使用原則 (Chinese only) Posted 2019-06-24

Singapore: Epilim® (valproate) – New restrictions on use Posted 2018-10-30

United Kingdom : Valproate Pregnancy Prevention Programme: actions required now ... Posted 2018-09-26