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MotherToBaby

Medications and More during pregnancy and breastfeeding

Statins

Selected References:

  • Bateman BT, et al. 2015. Statins and congenital malformations: cohort study. BMJ,350:h1035. 
  • Boyle AK, et al. 2019. Repurposing simvastatin as a therapy for preterm labor: evidence from preclinical models. FASEB J, 33:2743–2758.  
  • Chang J, et al. 2021. Perinatal outcomes after statin exposure during pregnancy. JAMA Netw Open, 4(12):e2141321.  
  • Cleary KL, et al. 2014. Challenges of studying drugs in pregnancy for off-label indications: pravastatin for preeclampsia prevention. Semin Perinatol, 38(8):523-527. 
  • Constantine MM, Cleary K. 2013. Pravastatin for the prevention of preeclampsia in high-risk pregnant women. Obstet Gynecol, 121(2 Pt 1):349-353. 
  • Döbert M, et al. 2021. Pravastatin versus placebo in pregnancies at high risk of term preeclampsia. Circulation, 144(9):670-679. 
  • Hirsch A, et al. 2022. The effect of statins exposure during pregnancy on congenital anomalies and spontaneous abortions: A systematic review and meta-analysis. Front Pharmacol, 13.  
  • Jay RH, et al. 1991. Effects of pravastatin and cholestyramine on gonadal and adrenal steroid production in familial hypercholesterolaemia. Br J Clin Pharmacol, 32(4):417–422. 
  • Kane AD, et al. 2022. Combined statin and glucocorticoid therapy for the safer treatment of preterm birth. Hypertension, 80(4).  
  • Kay HY, et al. 2025. Pregnancy and neonatal outcomes after fetal exposure to statins among women with dyslipidemia: a nationwide cohort. Eur J Pediatr, 184(6):340. 
  • Kazmin A, et al. 2007. Risk of statin use during pregnancy: a systematic review. J Obstet Gynaecol Can, 29(11):906. 
  • Kusters DM, et al. 2012. Statin use during pregnancy: a systematic review and meta-analysis. Expert Rev Cardiovasc Ther, 10(3):363-378. 
  • Maierean SM, et al. 2018. The potential role of statins in preeclampsia and dyslipidemia during gestation: a narrative review. Expert Opin Investig Drugs, 27(5):427-435. 
  • McElhatton P. 2005. Preliminary data on exposure to statins during pregnancy. Reprod Toxicol, 20:471-472. 
  • Morton S, Thangaratinam S. 2013. Statins in pregnancy. Curr Opin Obstet Gynecol, 25(6):433-440. 
  • Mudd LM, et al. 2012. Maternal lipids at mid-pregnancy and the risk of preterm delivery. Acta Obstet Gynecol Scand, 91(6):726–735.  
  • Ofori B, et al. 2007. Risk of congenital anomalies in pregnant users of statin drugs. Br J Clin Pharmacol, 64(4):496-509. 
  • Omolaoye TS, et al. 2022. Statins and Male Fertility: Is There a Cause for Concern? Toxics, 10(627):1-19. 
  • Raham DF, et al. 2021. Management of familial hypercholesterolemia in pregnancy. Curr Opin Lipidol, 32(6):370–377.  
  • Svendsen K, et al. 2025. Risk of adverse pregnancy outcomes and impact of statin use in pregnant women with familial hypercholesterolemia. Atherosclerosis, 408:120442.  
  • Taguchi N, et al. 2008. Prenatal exposure to HMG CoA reductase inhibitors: effects on fetal and neonatal outcomes. Reprod Toxicol, 26(2):175-177. 
  • U.S. Food and Drug Administration. 2021. Statins: drug safety communication – FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy. Posted July 20, 2021. Available at URL: https://www.fda.gov/safety/medical-product-safety-information/statins-drug-safety-communication-fda-requests-removal-strongest-warning-against-using-cholesterol.  
  • Vahedian-Azimi A, et al. 2021. Effects of statins on preeclampsia: a systematic review. Pregnancy Hypertens, 23:123-130. 
  • Vahedian-Azimi A, et al. 2021. A systematic review and meta-analysis on the effects of statins on pregnancy outcomes. Atherosclerosis, 336:1–11.  
  • Vahedian-Azimi A, et al. 2021. Fetal toxicity associated with statins: a systematic review and meta-analysis. Atherosclerosis, 327:59-67. 
  • Winterfeld U, et al. 2013. Pregnancy outcome following maternal exposure to statins: a multicentre prospective study. BJOG, 120(4):463-471. 
  • Wolfgang P, et al. 2004. Pregnancy outcome after medication with HMG-CoA reductase inhibitors in the first trimester. Reprod Toxicol, 19:254-255. 

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