New measures to avoid topiramate exposure in pregnancy in Europe
The regulatory agency has endorsed recommendations by PRAC that further restrictions, including a pregnancy prevention programme, should be put in place to avoid children being exposed to the medicine in the womb.
Source:
European Medicines Agency
SPS commentary:
PRAC assessed data from 3 observational studies of this medicine. Two of the studies suggest that children born to mothers with epilepsy and who were exposed to topiramate in the womb may have a two- to three-fold higher risk of neurodevelopmental disorders, in particular autism spectrum disorders, intellectual disability or attention deficit hyperactivity disorder (ADHD), compared with children born to mothers with epilepsy not taking antiepileptic medication.
In its review, PRAC also confirmed the known increased risk of birth defects and reduced growth of the unborn child when mothers receive topiramate during pregnancy. It was shown that birth defects will occur in 4 to 9 out of every 100 children born to women who take topiramate during pregnancy, compared with 1 to 3 out of every 100 children born to women who do not take such treatment. Further, around 18 in every 100 children were smaller and weighed less than expected at birth when mothers had taken topiramate during pregnancy, compared with 5 in every 100 children born to mothers without epilepsy and not taking antiepileptic medication.
The MHRA has previously said it will be considering the advice from PRAC and issuing guidance in due course.