其 他 安 全 警 示
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| Singapore: TOPAMAX® (topiramate): Safety measures to prevent exposure 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 the safety measures developed for TOPAMAX® (topiramate) to prevent its exposure during pregnancy. The product is indicated for adjunctive and monotherapy of epilepsy and for prophylaxis of migraine.
Topiramate can cause major congenital malformations and foetal growth restriction when used during pregnancy, and recent data also suggests a possible increased risk of neurodevelopmental disorders in children of mothers exposed to topiramate during pregnancy. Topiramate for prophylaxis of migraine is already contraindicated in pregnancy and in women of childbearing potential who do not use a highly effective method of contraception. Safety measures include performing pregnancy testing and use of a highly effective contraceptive method prior to initiating topiramate in women of childbearing potential, and informing patients of the risk of topiramate use during pregnancy. Treatment with topiramate should also be reassessed periodically to confirm if the pregnancy prevention measures are adhered to. Healthcare professionals are advised to weigh the benefits of topiramate therapy against the risks and consider alternative therapeutic options when treating women of childbearing potential.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/topamax-(topiramate)-safety-measures-to-prevent-exposure-during-pregnancy
In Hong Kong, there are 29 registered pharmaceutical products containing topiramate. All products are prescription-only medicines. So far, with regard to topiramate, the Department of Health (DH) has received 5 cases of adverse drug reaction, but these cases were not related to birth defects.
Currently, the package insert and/or sales pack label of locally registered topiramate-containing products should include safety information on fetal harm and the increased risk of cleft lip and/or cleft palate (oral clefts) in infants exposed to topiramate in utero.
Related news on the risk of birth defects associated with the use of topiramate during pregnancy was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 9 Jul 2022, with the latest update posted on 21 Jun 2024.
Letters to inform local healthcare professionals were issued by the DH on 4 Sep 2023. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Nov 8, 2024
Issued at HKT 16:00
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