PRAC July 2022 – New measures for medicinal products containing nomegestrol or chlormadinone and start of assessment of neurodevelopmental disorders when using topiramate
July 14, 2022
During its July 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends new measures to minimise the risk of meningioma with medicines containing nomegestrol or chlormadinone. The PRAC also starts the review on the risk of neurodevelopmental disorders with topiramate.
Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimise risk of meningioma
EMA’s safety committee (PRAC) has recommended new measures to minimise the risk of meningioma with medicines containing nomegestrol or chlormadinone, which are used for gynaecological and menstrual disorders, hormone replacement therapy and, at lower doses, as hormonal contraceptives (birth control).
New safety information for healthcare professionals
As part of its advice on safety-related aspects to other EMA committees, the PRAC discussed a direct healthcare professional communication (DHPC) containing important information for medicines containing chlormadinone- or nomegestrol.
PRAC starts review on risk of neurodevelopmental disorders with topiramate
PRAC has started a review of topiramate to assess new data on a potential risk of neurodevelopmental disorders in children who have been exposed to the medicine during pregnancy.