CHICAGO — The infants of mothers taking antiepileptic drugs showed no adverse cognitive effects as a result of breast-feeding, judging from the findings of a small, preliminary study.
“Concerns have been raised, but there are no prior formal studies examining the effect of breast-feeding in women taking antiepileptic drugs,” the study's lead author, Dr. Kimford Meador, the Melvin Greer Professor of Neurology at the University of Florida, Gainesville, where he serves as director of the epilepsy program and of the clinical Alzheimer program, said in an interview. Findings from “our study suggest that it is safe.”
Dr. Meador and his colleagues looked at 187 children of mothers enrolled in the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study. The NEAD study is a multicenter, prospective, parallel-group, observational study that is ongoing at 25 centers in the United States and the United Kingdom. Pregnant mothers with partial or primary generalized epilepsy taking pharmacologic monotherapy (including valproate, carbamazepine, phenytoin, or lamotrigine) were eligible to enroll. In this study, a blinded cognitive assessment of the children was conducted at 2 years old; follow-up assessments will be conducted at years 3, 4.5, and 6.
Compared with their non-breast-fed counterparts, the breast-fed children in this cohort (41%) actually had higher cognition, 98.1 vs. 89.5 on the Bayley Mental Developmental Index. However, Dr. Meador said that when investigators controlled for the mother's IQ, there was no significant difference between groups.
“The NEAD study is not randomized and was not specifically designed to examine the effects of breast-feeding,” he said, listing some of its limitations. Also, “there are only four drugs in the study.” However, “breast-feeding during antiepilepsy drug treatment doesn't appear to have a negative impact on a child's cognitive abilities.”
Speaking at the annual meeting of the American Academy of Neurology, Dr. Meador added that the 3-year follow-up data analysis is just being completed and that the final child in the study will reach age 6—the last follow-up point—in 2010.
Dr. Meador has received research support from GlaxoSmithKline Inc., UCB SA, Eisai Co., Myriad Genetics Inc., NeuroPace Inc., and SAM Technology Inc. His fellow researchers also disclosed financial or other relationships to drug companies.