SPC now states that a large amount of postmarketing data on pregnant women exposed to levetiracetam monotherapy (more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not suggest an increase in the risk for major congenital malformations. Only limited evidence is available on the neurodevelopment of children exposed to monotherapy in utero. However, current epidemiological studies (on about 100 children) do not suggest an increased risk of neurodevelopmental disorders or delays. It warns a decrease in levetiracetam plasma concentrations has been observed during pregnancy, which is more pronounced during the third trimester.
Gait disturbance has also been added to SPC as a rare adverse event.