HQ Team
September 2, 2023: A panel of the European Union’s health regulator, the European Medicines Agency, has warned against the use of topiramate medicines during pregnancy as it may result in serious birth defects.
The Pharmacovigilance Risk Assessment Committee (PRAC) stated that topiramate-containing medicines, also used for treating epilepsy and prevention of migraine, must not be taken for managing weight during pregnancy.
Additional measures need to be in place, in the form of a pregnancy prevention programme, to avoid exposure of children to topiramate in the womb, according to an EMA statement.
The medicine may increase the risk of neurodevelopmental problems in children after exposure during pregnancy.
Inform about risks
“For patients using topiramate for the treatment of epilepsy, the PRAC is now recommending that the medicine should not be used during pregnancy unless there is no other suitable treatment available,” according to the statement.
A woman or girl who is able to have children must be informed of the risks of taking topiramate during pregnancy and the need to avoid becoming pregnant while taking topiramate.
For all women of childbearing potential, alternative treatment options should be considered and the need for topiramate treatment should be reassessed at least annually.
Healthcare professionals should ensure that all patients who can become pregnant are fully aware of the risks of taking topiramate during pregnancy.
Oral cleft, autism
Exposure during pregnancy is associated with congenital malformations, developmental delay, and increased risk of recurrent malformations in future pregnancies, according to the US-based National Center for Biotechnology Information.
According to the clinical data from the NAAED (North American Antiepileptic Drug) pregnancy registry, there may be an increased risk of oral cleft when infants are exposed to topiramate.
A recent study indicates an increased risk of autism spectrum disorders and intellectual disability due to prenatal exposure to topiramate. Topiramate should be considered in pregnancy after a comprehensive risk-benefit evaluation, according to the center.
Sedation and diarrhea have been reported in breastfed infants, but most infants tolerate the drug in milk well. Parents should monitor the infant for diarrhea, drowsiness, irritability, weight gain, and developmental milestones.
