Palo Alto, CA—While a new study found no differences in neurodevelopmental outcomes between children with fetal exposure to newer antiseizure medications compared with those who were unexposed, a secondary analysis raised some concerns about possible effects, according to the researchers.

“The adverse effects of maternal postbirth anxiety emphasize the importance of screening mothers during pregnancy and postpartum and implementing interventions,” the study team led by Stanford University School of Medicine wrote. “Additional studies are needed to clarify the exposure-dependent effects.”

The report in Lancet Neurology noted that commonly used antiseizure medications such as lamotrigine and levetiracetam are generally considered effective and safe, especially compared with many first-generation epilepsy treatments that carried profound risks to unborn children.

“A blanket saying that all antiseizure medications are bad is overly simplistic and doesn’t make sense biologically,” stated senior author Page Pennell, MD, professor and chair of neurology at the University of Pittsburgh. “Being able to say that no, taking these medications will not put their future child at a greater risk of autism or learning disabilities, has a huge impact for women with epilepsy who are considering pregnancy.”

The study pointed out that the neurodevelopmental effects of fetal exposure to most antiseizure medications remain unclear. Researchers sought to investigate the effects of fetal exposure to commonly used antiseizure medications on neuropsychological outcomes at age 3 years.

Data come from the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs study, which is an ongoing prospective, observational, multicenter cohort study at 20 specialty epilepsy centers in the United States. The investigation focused on pregnancy outcomes in 456 women (aged 14-45 years) with and without epilepsy who were enrolled during pregnancy (≤20 weeks’ gestational age), and the 345 children who were born between December 19, 2012, and January 13, 2016.

Defined as the primary outcome for children at age 3 years was a blindly assessed Verbal Index score, which was calculated by averaging scores on the Naming Vocabulary and Verbal Comprehension subtests of Differential Ability Scales-II, Expressive Communication and Auditory Comprehension subscales of Preschool Language Scale-5, and Peabody Picture Vocabulary Test-4.

The researchers compared children of women with and without epilepsy and assessed the associations of medication exposures to outcomes in exposed children.

The results indicated that Verbal Index scores at age 3 years did not differ for the 284 children of women with epilepsy (adjusted least-square mean 102.7; 95% CI, 101.4-103.9) versus 87 without epilepsy (adjusted least-square mean 102.3, 99.8-104.7).

Significant risk factors for reduced Verbal Index scores included maternal intelligence quotient, maternal education, postbirth anxiety, gestational age at enrolment, and child’s sex and ethnicity, the study noted.

“For Verbal Index scores, antiseizure medication exposure effects were not seen for maximum third-trimester blood concentrations (n = 258; adjusted parameter estimate –2.9, 95% CI –6.7 to 1.0), according to the report. “However, in secondary analyses, exposure-dependent effects were present on multiple cognitive measures, which varied by medication.”

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