Prenatal statin exposure and adverse birth outcomes in Asian women: a systematic review and meta-analysis

The safety of statin use during pregnancy remains controversial. We aimed to evaluate the association between prenatal statin exposure and pregnancy outcomes in Asian women, including low birth weight, preterm birth, and congenital anomalies. We conducted a PRISMA-compliant systematic review and meta-analysis of studies in Asian populations evaluating prenatal statin exposure. PubMed, Embase, the Cochrane Library, Web of Science, and trial registries were searched through January 31, 2026. Eligible randomized and observational studies included Asian populations and reported low birth weight, preterm birth, or congenital anomalies. Adjusted risk ratios were pooled using random-effects inverse-variance models, and risk of bias was assessed with standard tools. Three nationwide observational cohort studies from Taiwan and South Korea were included in the quantitative synthesis, and one Indonesian randomized trial of pravastatin for preeclampsia prevention was reviewed qualitatively. Prenatal statin exposure was not associated with congenital anomalies (RR, 0.98; 95% CI, 0.89–1.08; I 2 = 0%), but was associated with low birth weight (RR, 1.27; 95% CI, 1.07–1.49; I 2 = 49%). The association with preterm birth was not statistically significant (RR, 1.24; 95% CI, 0.95–1.62; I 2 = 87%). Sensitivity analyses restricted to exposed versus unexposed comparisons yielded similar conclusions. The available Asian evidence, largely derived from nationwide East Asian cohorts, suggests no clear association between prenatal statin exposure or continuation and congenital anomalies. A modest association with low birth weight was observed, whereas evidence for preterm birth remained inconclusive. The low-birth-weight finding should be interpreted cautiously because of residual confounding, comparator heterogeneity, prematurity-related low birth weight, and pharmacological heterogeneity across statins. PROSPERO CRD420251235975