Date of Graduation
Master of Science in Physician Assistant Studies
Brent Norris, PA-C, MS
Annjanette Sommers, PA-C, MS
Statins are the most common and effective drug used to treat hyperlipidemia. Based on animal studies showing potential teratogenic effects at high doses, statins are contraindicated in pregnancy due to concern that they would disrupt cholesterol biosynthesis for the fetus. This review evaluates the current evidence of harm caused by statins when taken within the first trimester of pregnancy.
An exhaustive literature search was conducted in June 2015 using MEDLINE-Ovid, CINAHL, Evidence-Based Medicine Reviews Multifile, and Web of Sciences databases. Keywords searched included statin, pregnancy, and congenital malformation. The search was further narrowed down to include only English-language articles and human studies published within the last ten years. Articles within a ten-year period that evaluated the possible congenital malformations of statin drugs in first trimester women were included. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group Guidelines was used to evaluate the quality of the remaining eligible articles.
Results Three articles met the inclusion criteria for this systematic review. One retrospective study looked at 886 996 completed pregnancies, 1152 of which took a statin during their first trimester, and found no significant teratogenic effects from first trimester statin therapy. The second retrospective cohort study with 288 pregnant women found no significant teratogenic effects from first trimester statin therapy. The prospective observational study included 498 women found no significant teratogenic effects from first trimester statin therapy. All studies were rated as having low quality of evidence based on GRADE guidelines.
Statins may not be as harmful during pregnancy as the FDA’s class X designation advises, but there is not enough statistical strength to change the current recommendation of the discontinuation of statins during pregnancy. Additional research to evaluate the long-term effects of in utero exposure to statins is needed.
Statin, pregnancy, congenital malformation
Hoffman, Alexander E., "Risk of Congenital Malformations With Statin Therapy During the First Trimester of Pregnancy" (2016). School of Physician Assistant Studies. 583.