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Developmental disabilities after in utero exposure to topiramate Topiramate is known to cause congenital abnormalities when administered to pregnant women but it is also associated with an increased risk of neurodevelopmental disorders, advises the Malaysian National Pharmaceutical Regulatory Authority (NPRA). Its use during pregnancy should be considered only if the potential benefits outweigh the potential risks.In December 2022, the European Medicines Agency (EMA) initiated a safety review of the risk of neurodevelopmental disorders in children exposed to topiramate in utero. This followed the publication of findings of the Nordic register-based study of antiepileptic drugs in pregnancy (SCAN-AED) which found significantly increased risks of autism spectrum disorders (ASD) and developmental disabilities in children whose mothers took topiramate during pregnancy. The EMA is conducting an in-depth review of the benefits and risks of topiramate use in pregnant women and women of childbearing potential, and is assessing the need for additional measures to minimise the risks associated with topiramate use in these women.As of March 2023, the NPRA had received 43 reports with a total

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Publisher

Springer Science and Business Media LLC

Published

2023

Language

EN

Field

Medicine (Health Sciences)