New anti-epileptic drugs used during pregnancy do not affect the development of the brain in children

News Release

Wednesday 27 November 2024

An NIH-funded study sheds light on the safety of two common antiseizure drugs lamotrigine and levetiracetam.

Children of mothers who took certain antiseizure medications during pregnancy did not have adverse neurodevelopmental outcomes at age 6, according to a long-term study sponsored by the National Institutes of Health ( NIH). The lesson was published in JAMA Neurology.

“Managing seizures during pregnancy is an important part of prenatal care for women with epilepsy, but for years, the effects of new anti-seizure medications on their children were unknown. ,” said Adam Hartman, MD, program director of the NIH’s National Institute of Neurological Disorders and. Stroke (NINDS). “One of the main aspects of this study was to correlate the mental abilities of children with the levels of drugs in the mothers’ blood. This opens the door for future work and may inform better dosing strategies. ”

Treating epilepsy during pregnancy is a challenge, as some antiseizure medications, especially older drugs such as valproate, are known to cause serious birth defects and cognitive problems in children, including lower IQ. low and autism spectrum disorders. The new antiepileptic drugs that are widely used today are generally considered safe, but little is known about how they affect cognitive function in children after exposure to the baby.

In the study, the researchers examined the language skills of 387 6-year-old children (298 were born to women with epilepsy who took antiseizure medication). The children were tested on different speaking skills, including words and matching spoken words to pictures. There was no difference between the children of women who took the medication and those who did not. Many women took lamotrigine, levetiracetam, or a combination of both drugs during pregnancy and after pregnancy.

“What makes this study meaningful is that when you test a child at 6 years old, the tests are much stronger than in the early years, especially 2-year-olds. There is a measurable impact on performance of school and the results predict cognitive abilities in adults,” said Kimford Meador, MD, study co-researcher and professor of neurology at Stanford University.

Finding the most effective and safest doses during pregnancy is also a challenge, and the risks often differ between anti-falling drugs. Early studies from the same research group showed that high doses of levetiracetam may lead to poorer cognitive outcomes at 2 and 3 years of age, and worse performance at 4 years of age. and a half, but the general results of all years were good.

“We need to strike a balance to ensure that there is enough medicine to protect the mother and her developing baby from falling, but not too much where we put the child at risk,” said said Dr. Meador.

The study also found that the use of folate during the first 12 weeks of pregnancy was associated with better psychological and behavioral outcomes, even at higher rates. Folate is an important nutrient that can help prevent birth defects in a developing baby’s brain and spine. This applied to children of women with and without epilepsy. Doses as high as or greater than 4 mg per day had no adverse effects, contrary to previous studies that found long-term risks associated with high doses of folic acid.

This report is part of the Maternal and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study, a prospective, long-term study looking at how antiseizure drugs affect pregnant women with epilepsy and their children in from birth until they are 6 years old. Led by Dr. Meador and Page Pennell, MD, chair of neurology at the University of Pittsburgh, the study took place in 20 medical centers across the United States.

Other studies have not revealed any adverse effects of antiseizure medications during breastfeeding. The researchers point out that more research needs to be done to understand the risks of high doses of folate and unusual antiseizure medications, including new drugs on the market.

This research was supported by NINDS and Eunice Kennedy Shriver National Institute of Child Health and Human Development (U01NS038455 and U01NS050659), and was part of the MONEAD study (NCT01730170).

About the National Institute of Neurological Disorders and Stroke (NINDS): NINDS is the nation’s leading funder of research on the brain and nervous system. The mission of NINDS is to seek basic knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.

About the National Institutes of Health (NIH):The NIH, the nation’s national medical research agency, includes 27 Institutes and Centers and is part of the United States Department of Health and Human Services. NIH is a major federal agency that conducts and supports basic, clinical, and translational medical research, and investigates the causes, treatments, and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH…Turning Discovery into Health^®

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