Paternal Valproate Use and Neurodevelopmental Disorder and Congenital Malformation Risk in Offspring

Is paternal valproate vs lamotrigine or levetiracetam exposure associated with neurodevelopmental disorder or congenital malformation risk in children?In this cohort study of 5721 offspring in Denmark, Norway, and Sweden whose fathers were exposed to either (1) valproate or (2) lamotrigine or levetiracetam, paternal exposure to valproate within 3 months prior to conception was associated with significantly increased risk of neurodevelopmental disorders vs lamotrigine or levetiracetam. Risk of congenital malformations was not different between exposure groups, although estimates were heterogenous.These findings suggest that health care practitioners should consider the potential risks associated with paternal valproate exposure within the 3-month period before conception and discuss alternative treatments with male patients of reproductive age.

Corresponding Author: Sandrine Colas, MPH, PhD, Patient Safety sandrine.colas@sanofi.com).

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