ADR that result in revision of patient information
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| Singapore: Epilim® (valproate): Updates and new measures relating to the risk of neurodevelopmental disorders in children of fathers treated with valproate |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Sanofi-Aventis Singapore Pte. Ltd. as a follow-up to update on the potential risk of neurodevelopmental disorders (NDDs) in children of fathers treated with valproate in the 3 months prior to conception compared to those treated with lamotrigine or levetiracetam, as well as the new measures introduced to address this risk.
The adjusted cumulative risk of NDDs and pooled adjusted hazard ratio have been revised based on further analysis of previously published study results. In addition to informing male patients of the potential risk of NDDs in children of fathers treated with valproate in the 3 months prior to conception, prescribers are advised to discuss with male patients on alternative therapeutic options, the need for effective contraception while using valproate and for 3 months after stopping treatment and the need for regular (at least annual) review of treatment. The Singapore package insert for Epilim® (valproate) has been updated to reflect these recommendations, and the updated educational materials will be disseminated to healthcare professionals when available.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/epilim-(valproate)-updates-and-new-measures-relating-to-the-risk-of-neurodevelopmental-disorders-in-children-of-fathers-treated-with-valproate
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 15 cases of adverse drug reaction related to valproate, but these cases were not related to neurodevelopmental disorders in children after paternal exposure to valproate.
Related news was previously issued by HSA, the United Kingdom Medicines and Healthcare products Regulatory Agency and European Medicines Agency (EMA), and was posted on the Drug Office website since 22 Mar 2023, with the latest update posted on 13 Jan 2024. Letters to inform local healthcare professionals were issued by the DH on 22 Mar 2023.
In light of the above HSA’s announcement, with the recent recommendations of EMA, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Wednesday, Jan 24, 2024
Issued at HKT 16:30
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