Long-term neurodevelopmental follow-up of children exposed to pravastatin in utero

If given in early pregnancy pravastatin, (a drug used to lower cholesterol) may decrease the risk of developing preeclampsia. This particular type of drug, however, originally received an X designation by the FDA.  An X designation is given when, “Studies in animals or humans have demonstrated fetal abnormalities…and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.” The X classification for pravastatin was based primarily on the fact that there was no known indication for use in pregnancy, and therefore any possible risk outweighed benefit.  There was also some concern about fetal anomalies, but the latter was not confirmed in follow-up studies.

The current study followed-up children involved in two small pilot studies where women were randomly assigned to take pravastatin or placebo for preeclampsia prevention. Both studies were too small to document a significant decrease in the incidence of preeclampsia, but did  show that doses of 10 and 20 mg were well-tolerated and there were no short-term adverse effects on the pregnant persons or their newborns. Researchers were able to examine 30 of the 40 children born during these two studies at an average age of 4.7 years of age.  The children underwent extensive neuro-developmental testing. In addition, medical examinations were conducted, including height and weight, and information collected about medical history, vision problems, & hearing loss. There were no differences between those exposed to pravastatin and those who were not.

Take home: Based on limited data, pravastatin use during pregnancy does not appear to have any long-term adverse effects on children. This information will be useful for gaining approval for larger studies to see if pravastatin is actually useful in preventing preeclampsia.

For more on pravastatin.

Link: https://pubmed.ncbi.nlm.nih.gov/36842489/

Citation: Costantine MM, Clifton RG, Boekhoudt TM, Lawrence K, Gyamfi-Bannerman C, Wisner KL, Grobman W, Caritis SN, Simhan HN, Hebert MF, Longo M, Saade GR; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network and the Obstetric-Fetal Pharmacology Research Centers Network. Long-term neurodevelopmental follow-up of children exposed to pravastatin in utero. Am J Obstet Gynecol. 2023 Feb 24:S0002-9378(23)00111-4. doi: 10.1016/j.ajog.2023.02.016. Epub ahead of print. PMID: 36842489.

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Each quarter, our team of science writers reviews the most current research studies related to hypertensive disorders of pregnancy and summarizes those studies of greatest interest and potential impact to our community, including research studies related to risk assessment, diagnosis, prevention, and treatment. Special thanks to our volunteer research team, who under the leadership of Dr. Elizabeth Sutton, make Research Roundup possible, and to our Patient Advisory Council, who reviews these materials from the patient perspective.