Pravastatin exposure during pregnancy carries no adverse neurodevelopmental risk for offspring

Children born to mothers who were taking pravastatin during the second and third trimesters of pregnancy do not appear to have any identifiable long-term neurodevelopmental safety risks, as reported in a study.

For the study, researchers performed an ancillary follow-up cohort study of the offspring of women who participated in the Obstetrics Fetal Pharmacology Research Centers Network pilot trials of pravastatin for pregnancies at high-risk pre-eclampsia.

Children’s motor, cognitive, and developmental outcomes were assessed using the Child Behavior Checklist that the parents completed and validated tools that a certified and blinded study psychologist completed.

The analysis included 30 children born to mothers in the original trial, among whom 15 had in-utero exposure to pravastatin and 15 to placebo. The follow-up duration overall was 4.7 years and did not significantly differ in the pravastatin and placebo groups.

The child’s body mass index (BMI) percentiles per sex and corrected age, rates of extremes of BMI percentiles, and the report of any other medical or developmental complications were similar in the pravastatin and placebo groups.

None of the children in the pravastatin group had any limitation in motor assessment. On the other hand, two children (13.3 percent) had difficulty walking and four (26.7 percent) had reduced manual abilities in the placebo group. Furthermore, children in the pravastatin vs placebo group had markedly higher general mean conceptual ability score (mean, 98.2 vs 89.7; p=0.13) and were less likely to have a score <85 (ie, one standard deviation lower than the mean; 15.4 percent vs 35.7 percent; p=0.38).

Finally, there were no significant between-group differences in the parents’ report on the Child Behavior Checklist.