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Agenzia Italiana del Farmaco
EMA: New measures to avoid topiramate exposure in pregnancy - EMA: New measures to avoid topiramate exposure in pregnancy
EMA: New measures to avoid topiramate exposure in pregnancy
On 11 October 2023, the CMDh endorsed new measures recommended by EMA’s safety committee (PRAC) in September to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of neurodevelopmental problems after exposure during pregnancy.
Topiramate is already known to cause serious birth defects when used during pregnancy. the measures will be directly implemented by the Member States where these medicines are authorised.
Published on: 13 October 2023
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