其 他 安 全 警 示
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| Singapore: TOPAMAX® (topiramate) TABLETS 25mg, 50mg and 100mg: Risk of neurodevelopmental disorders (autism spectrum disorder and intellectual disability) in children following in utero exposure and reminder on use of topiramate during pregnancy (English only) |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Johnson & Johnson International (Singapore) Pte Ltd to inform healthcare professionals of new safety updates regarding an increased risk of neurodevelopmental disorders (autism spectrum disorder and intellectual disability) in children exposed to topiramate in utero, as well as to remind about the existing risks of congenital abnormalities related to the use of topiramate during pregnancy. Revisions to the Singapore package inserts for TOPAMAX® are being made, including the recommendation of highly effective contraception in women of childbearing potential before treatment initiation and informing patients of the risk related to the use of topiramate during pregnancy.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/topamax-topiramate-tablets-25mg-50mg-and-100mg-risk-of-neurodevelopmental-disorders-autism-spectrum-disorder-and-intellectual-disability-in-children-following-in-utero-exposure-and-reminder-on-use-of-topiramate-during-pregnancy
In Hong Kong, there are 32 registered pharmaceutical products containing topiramate. All products are prescription-only medicines. So far, the Department of Health (DH) has received 4 cases of adverse drug reaction related to topiramate, but these cases were not related to neurodevelopmental disorders in children exposed to topiramate in utero.
Currently, the package insert and/or sales pack label of locally registered topiramate-containing products should include safety information on the increased risk of cleft lip and/or cleft palate (oral clefts) in infants exposed to topiramate in utero.
Related news on the initiation of safety review of topiramate and the risk of neurodevelopmental disorders in children with in utero exposure was previously issued by European Medicines Agency and the United Kingdom Medicines and Healthcare products Regulatory Agency, and were posted on the Drug Office website since 9 Jul 2022, with the latest update posted on 3 Sep 2022. As the reviews are ongoing, the DH will remain vigilant on the conclusion of the reviews and any safety updates of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Tuesday, Mar 7, 2023
Issued at HKT 12:00
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