Antiseizure Drugs Don’t Harm Young Children’s Neurodevelopment

Most mothers who took prescription antiseizure drugs during pregnancy can exhale a sigh of relief: A new study published today in the journal Lancet Neurology discovered that young infants exposed to routinely administered drugs in pregnancy do not have worse neurodevelopmental outcomes than children of healthy moms.

Antiseizure drugs such as lamotrigine and levetiracetam are widely deemed effective and safe, especially when compared to several first-generation epilepsy treatments that posed significant dangers to the unborn child. While epilepsy may no longer be a barrier to raising a baby, there is still a lack of understanding about how medicines used by the woman affect maternal and child outcomes after birth.

The new study reassures patients and provides guidance to neurologists who must strike a delicate balance between providing medicine dosages that decrease mother’s seizures while posing no additional risks of neurological issues for the baby.

“A blanket saying that all antiseizure medications are bad is overly simplistic and doesn’t make sense biologically,” said senior author Page Pennell, M.D., 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.”

Epilepsy is a neurological illness characterized by abnormal electrical activity in the brain that affects approximately one million pregnant women in the United States. For decades of the twentieth century, the illness was considered incompatible with pregnancy due to its rapid and devastating seizures and limited number of treatments, which posed major hazards to the growing fetus, albeit that landscape is progressively changing.

The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) project began two decades ago with the purpose of providing high-quality information on how antiepileptic medicines affect both the mother and the child. The prospective observational study recruited women with epilepsy from twenty medical sites across the United States and tracked them and their offspring during pregnancy and for several years after birth.

Previous research from the study underlined the importance of carefully monitoring and adjusting the dosage of antiseizure drugs to obtain optimal epileptic control without jeopardizing the fetus’s health. The new study sought to determine whether exposure to these medicines has long-term neurological consequences for children.

To measure the effects of fetal drug exposure, children as young as three years old were tested for vocabulary, verbal understanding, and the capacity to describe simple drawings. Children of epileptic mothers were just as good as children of non-epilepsy mothers at verbally describing simple items and pictures. Their capacity to interpret language was similarly comparable to children of the same age born to women who did not have epilepsy, demonstrating that both lamotrigine and levetiracetam provide low risks for adversely altering cognitive outcomes.

Researchers discovered that a high dose of levetiracetam in the third trimester of pregnancy was associated with adverse neurodevelopmental effects on the infant in a secondary study, and they advocate extremely cautious monitoring of blood levels of this medicine and judicious dosing procedures. However, researchers warn out that more research is needed to see if the same holds true for other antiseizure drugs that are less commonly used.

Another significant element that clinicians must address is screening for mood and anxiety disorders. Researchers discovered that heightened maternal worry and, to a lesser extent, sadness have a deleterious effect on newborns as part of the study.

“The findings provide valuable information for women with epilepsy, but there is still much to do as we don’t know the risks for most antiseizure medications,” said lead author and one of several principal investigators of the study Kimford Meador, M.D., professor of neurology at Stanford University.

“For many years, prescribers did not have good information on cognitive outcomes of children exposed in utero to more recently approved antiseizure medicines,” said Adam Hartman, M.D., program director in the NINDS Division of Clinical Research and NINDS project scientist for MONEAD. “This study represents another important step in advancing our knowledge; however, there is more confirmatory work to be done, particularly for the secondary outcomes.”

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