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o Babies born to mothers taking this during pregnancy have a 30 to 40% risk of developmental disability and 10% risk of birth defects o New guidance says that it must not be used in any girl or woman able to have children unless there is a pregnancy prevention programme (PPP) in place o There is no safe dose that can be used in pregnancy o In 2020 increasing realisation of lack of awareness of the risk - need for extra guidelines for prescriber and patient

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