• Journal Article

Challenges of studying drugs in pregnancy for off-label indications: Pravastatin for preeclampsia prevention

Citation

Cleary, K. L., Roney, K., & Costantine, M. (2014). Challenges of studying drugs in pregnancy for off-label indications: Pravastatin for preeclampsia prevention. Seminars in Perinatology, 38(8), 523-527. DOI: 10.1053/j.semperi.2014.08.019

Abstract

Statins (3-hydroxy-3 methyl-glutaryl coenzyme-A reductase inhibitors) are the most commonly prescribed cholesterol-lowering medications due to their efficacy in reducing cardiovascular mortality and morbidities, tolerability, and safety profiles. Based on pathophysiologic similarities between cardiovascular disease and preeclampsia, a common and dangerous complication of pregnancy, there is an increasing interest in studying this class of medications during pregnancy to prevent and/or treat preeclampsia. Undergoing such a study, which entails the use of a pregnancy class X medication for an off-label indication in pregnancy, requires intensive multidisciplinary involvement of a group of experts in basic and clinical pharmacology, research methods, pregnancy physiology and maternal-fetal medicine, as well as U.S. Food and Drug Administration (FDA) regulatory guidelines and practice. Issues of potential fetal risk, altered maternal-fetal pharmacokinetics and pharmacodynamics, and regulatory challenges are real, and must be carefully considered in the process of research in this arena