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PRAC recommends new measures to avoid exposure to topiramate during pregnancy

🔶The EMA's safety committee (PRAC) recommends new measures to avoid exposure of children to topiramate-containing drugs in the womb, as the drug may increase the risk of neurodevelopmental problems after exposure during pregnancy. Topiramate is already known to cause serious birth defects when used during pregnancy.

🔶Liquids containing topiramate are used in the EU for the treatment of epilepsy and the prevention of migraine. In some EU countries, the drug is also used in combination with phentermine to reduce body weight. Currently, topiramate cannot be used to prevent migraine or control weight during pregnancy, and patients who may become pregnant must use effective birth control while taking topiramate.

🔶For patients using topiramate to treat epilepsy, PRAC currently recommends that the drug should not be used during pregnancy unless no other suitable treatment is available.

🔶PRAC also recommends additional measures, in the form of a pregnancy prevention programme, to avoid exposure of children to topiramate in the womb. These measures will inform any woman or girl who may have children about the risks of taking topiramate during pregnancy and the need to avoid becoming pregnant while taking topiramate.

🔵The review of topiramate was initiated at the request of the French medicines agency, in accordance with Article 31 of Directive 2001/83/EC. This is linked to the safety signal review, which started in July 2022 and ended in September 2022.

🟧As all topiramate-containing medicines are authorised at national level, the PRAC recommendations will now be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures - People (CMDh), which will take a position. The CMDh is the body representing the EU Member States plus Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised through national procedures across the EU.

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