PRAC September 2022 –Reviews of topiramate and pholcodine medicines started

September 15, 2022

During the September 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral of topiramate and also started a referral of pholcodine medicines.

Source: FAMHP

PRAC starts review of topiramate use in pregnancy and women of childbearing potential
EMA’s safety committee (PRAC) has started a review of topiramate and the risk of neurodevelopmental disorders in children whose mothers were taking topiramate during pregnancy.

PRAC: Review of pholcodine medicines started
EMA has started a review of medicines that contain pholcodine following concerns that their use may put people at risk of developing anaphylactic reactions (a sudden, severe and life-threatening allergic reaction) to certain medicines called neuromuscular blocking agents (NMBA).

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