Table 3.

Summary of major studies assessing the risk of congenital anomalies with the use of statins in pregnancy

Study	Year	Study type	Population/ exposure	Statin (n)	Control (n)	Congenital anomalies
Edison et al80	2004	case series	Ascertained reports of exposure to statin reported to the FDA (1987 to 2001)	n=70; pravastatin n=20	None	22 reports of congenital anomalies, none with pravastatin
Ofori et al63	2007	Population based registry	Statin use within one year before and during pregnancy (1997–2003)	n=64; pravastatin n=12	Use of statins only before conception (1 year – 1 month) (n=67)	Exposed vs non-exposed: 4.7% vs.10.5% aOR 0.36 (95% CI 0.06–2.18) No anomalies with pravastatin
Taguchi et al81	2008	Prospective observational cohort	Pregnant women exposed to statins and contacting the motherisk teratology information service (1998 to 2005)	n=64; pravastatin n=6	No exposure to known teratogens (n=64)	Exposed vs non-exposed: 2.2% vs 1.9%; p = 0.93
Winterfeldet al82	2013	Multicenter observational prospective	Pregnant women exposed to statins and contacting the European teratology information services (1990–2009)	(n=249; pravastatin n=32)	Exposure to agents known to be non-teratogenic (n=249)	Exposed vs non-exposed.: 4.1% vs. 2.7%, OR 1.5 (95% CI 0.5 – 4.5)
Bateman et al68	2015	cohort	Women with live birth, from US Medicaid data (2000–2007)	n=1152; pravastatin n=75	No statin use in the first trimester (propensity score matched group)	Exposed vs non-exposed: 6.3% vs. 3.6%, aOR 1.04 (95% CI 0.85–1.37)
Costantine et al58	2016	Randomized trial	Women with history of prior preeclampsia that required preterm delivery before 34 weeks, randomized to 10mg pravastatin vs placebo between 12–16 weeks.	Pravastatin (10)	Placebo (n=10)	One fetus in the pravastatin group had hypospadias and another had coarctation of the aorta (diagnosed postnatally), whereas in the placebo group, one fetus had polydactyly and another had ventriculomegaly.
Lefkou et al59	2016	Prospective cohort	Women with antiphospholipid syndrome and poor obstetric history.	Pravastatin (n=11)	Patients receiving standard of care (n=10)	n/a (No reports of congenital anomalies)
McGrogan et al83	2017	cohort	Women using statins before or during the 1st trimester (1992 – 2009)	n = 281, pravastatin n=8	No statin use (n = 2,643)	Exposed vs non-exposed: 3.2% vs. 2.8%, OR* 1.6 (95% CI 0.72–3.64)
Ahmed et al60	2020	Randomized trial	Women with early-onset preeclampsia, randomized to 40mg pravastatin vs placebo	Pravastatin (30)	Placebo (n=32)	n/a (no detectable adverse effects on the short-term health of offspring)

^*Unadjusted OR calculated from data in report.