Statins may be okay to use in pregnant patients
You will hear controversy about whether statins are okay to use in pregnant patients. This is coming up because labelling for statins in the U.S. will no longer say they're contraindicated during pregnancy. Experts now say statin benefits may outweigh risks in the very small group of pregnant patients at very high CV risk. This includes pregnant patients with homozygous familial hypercholesterolemia, or who've had a heart attack or stroke. Contraindications in labelling stem partly from animal studies suggesting birth defects with higher-than-usual statin doses. Observational studies in humans don't suggest this risk.
But point out caveats. For example, most evidence is based on exposure to statins in the first trimester, not throughout pregnancy. And there are still questions about whether reducing cholesterol synthesis impacts fetal development whether statins increase miscarriage risk or if some statins are safer than others.
Don't anticipate big changes in practice. Very few patients of childbearing age need a statin. In most cases, continue to advise stopping a statin 1 to 2 months before a planned pregnancy. Explain that it's usually okay to hold statins during pregnancy, such as for primary prevention in a patient over age 40 with type 2 diabetes since plaque buildup is a chronic process. But don't be surprised if there are individual exceptions for statin use in the rare pregnant patient at very high CV risk. If you see these Rxs, document your prescriber and patient discussions.
Don't think of ezetimibe or a PCSK9 inhibitor instead, there aren't enough data yet to guide their use in pregnancy. Keep in mind that small amounts of statins may pass into breast milk. If patients took a statin while pregnant, advise reweighing risks, benefits, and alternatives during breastfeeding.
References
- FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy. https://www.fda.gov/media/150774/download.
- Pearson GJ, Thanassoulis G, Anderson TJ, et al. 2021 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in Adults. Can J Cardiol. 2021;37(8):1129-1150.
- Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;73(24):3168-3209.
- Karalis DG, Hill AN, Clifton S, Wild RA. The risks of statin use in pregnancy: A systematic review. J Clin Lipidol. 2016 Sep-Oct;10(5):1081-90.
