引 致 更 改 给 病 人 的 产 品 资 讯 的 药 物 不 良 反 应 警 示
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| European Union: PRAC starts review on risk of neurodevelopmental disorders with topiramate (English only) |
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The European Medicines Agency (EMA) announces that its Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of topiramate to assess new data on a potential risk of neurodevelopmental disorders in children who have been exposed to the medicine during pregnancy.
Topiramate is indicated for the treatment of epilepsy, either used alone (monotherapy) or in conjunction with other medicines (combination therapy), as well as for the prevention of migraine. The use of topiramate by pregnant women is already known to increase the risk of birth defects. For that reason, women with epilepsy are advised to avoid becoming pregnant whilst being treated with topiramate, and to consult their doctor for advice in case they wish to become pregnant. Pregnant women, or women of childbearing potential not using highly effective birth control, must not be treated for prevention of migraine.
Recently, a study investigating the risk of neurodevelopmental disorders, including autism spectrum disorder and intellectual disability, associated with several anti-epileptic drugs, including topiramate, has been published. The study is based on Nordic registry data and includes more than 24,000 children exposed in utero to at least one anti-epileptic drug, including 471 who were exposed to topiramate.
The study conclusions suggest a possible increase in the risk of autism spectrum disorders, intellectual disability and child neurodevelopmental disorders with the exposure to topiramate during pregnancy.
In light of the importance of this new information, the PRAC decided that further assessment is warranted to determine the scope and the best regulatory procedure to assess these potential risks.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-july-2022
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 are not related to neurodevelopmental disorders. In light of the above EMA’s announcement, the DH will remain vigilant on the conclusion of the review and any safety updates issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, July 09, 2022
Issued at HKT 11:15
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