其他安全警示

Singapore: Epilim® (valproate) – New restrictions on use (English Only)

The Health Sciences Authority (HSA) announces that Sanofi-Aventis would like to inform healthcare professionals about the new restrictions that have been put in place to prevent valproate exposure during pregnancy. These new restrictions include contraindications for the use of valproate during pregnancy and the implementation of a pregnancy prevention programme.

Healthcare professionals are reminded that children exposed in utero to valproate are at a high risk of serious developmental disorders (up to 30-40%) and of congenital malformations (approximately 10%) and valproate should not be used in female children and women of childbearing potential unless other treatments are ineffective or not tolerated. To further strengthen the measures to prevent valproate exposure during pregnancy, valproate is now contraindicated in pregnancy for the treatment of bipolar disorder. For the treatment of epilepsy, valproate is contraindicated in pregnancy unless there are no suitable alternatives. For women of childbearing potential, valproate should only be used in exceptional cases and the conditions of the pregnancy prevention programme must be fulfilled. A set of educational materials comprising a Guide for Healthcare Professionals, a Patient Guide and a Patient Card, has also been developed by Sanofi-Aventis to inform healthcare professionals and patients/caregivers on the risks of valproate and the conditions for use. Sanofi-Aventis will be updating the package inserts of all Epilim® products to reflect the new restrictions and conditions for use of valproate.

Please refer to the following website in HSA for details: http://www.hsa.gov.sg/content/hsa/../epilim-valproatenewrestrictionsonuse.html

In Hong Kong, there are 11 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 9 cases of adverse drug reaction related to valproic acid or valproate, but these cases are not related to adverse effects in new-born babies whose mothers took valproate for their medical conditions.

Related news on the recent review of valproate was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 13 Mar 2017, with the latest update posted on 26 Sep 2018. Letters to local healthcare professionals to draw their attention to the European Medicines Agency (EMA) recent review were also issued on 12 Feb 2018.

In Dec 2014, the Registration Committee of the Pharmacy and Poisons Board (Registration Committee) discussed the findings of an EMA previous review on the risk of valproate products in pregnancy and had decided that warnings and precautions on the risk of pregnancy should be included in valporate products. In light of the news related to the recent review from overseas authorities and the above HSA announcement, the matter will be discussed by the Registration Committee. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.

Ends/Tuesday, Oct 30, 2018
Issued at HKT 16:00

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