- •Zonisamide can act as a teratogen in animal models, but the magnitude of any potential teratogenic effect is not well established in human pregnancies.
- •From UK and Ireland zonisamide monotherapy data we have identified a possible signal of teratogenicity which needs to be explored further.
- •Zonisamide has been found to be associated with small for gestational age status in 21% of exposures.
- •Mandatory reporting of outcomes would speed up efforts to determine the level of risk associated with lower frequency prescribed antiepileptic drugs.
Methods and materials
- The use of antiepileptics in migraine prophylaxis.Headache. 2016; 56: 603-615
- Zonisamide: chemistry, mechanism of action, and pharmacokinetics.Seizure. 2004; (13 Suppl 1discussion S10): S5-S9
- Preliminary report on teratogenic effects of Zonisamide in the offspring of treated women with epilepsy.Epilepsia. 2004; 37: 1242-1244
- Comparative safety of antiepileptic drugs during pregnancy.Neurology. 2012; 78: 1692-1699
- North American antiepileptic drug pregnancy registry. Fetal growth and premature delivery in pregnant women on antiepileptic drugs.Ann Neurol. 2017; 82: 457-465
- Fetal loss and malformations in the MONEAD study of pregnant women with epilepsy Neurology.MONEAD Investigator Group. 2020; 94: e1502-e1511
- EURAP study group. Dose-dependent risk of malformations with antiepileptic drugs: an analysis of data from the EURAP epilepsy and pregnancy registry.Lancet Neurol. 2011; 10: 609-617
- Malformation risks of antiepileptic drug monotherapies in pregnancy: updated results from the UK and Ireland Epilepsy and Pregnancy Registers.J Neurol Neurosurg Psychiatry. 2014; 85: 1029-1034
- Pregnancy and epilepsy; meeting the challenges over the last 25 years: the rise of the pregnancy registries.Seizure. 2017; 44: 162-168
- Zonisamide serum concentrations during pregnancy.Epilepsy Res. 2018; 144: 25-29
- First do no harm: the report of the independent medicines and medical devices safety review.July 2020 (https://www.immdsreview.org.uk/Report.html)