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

Kirsten Lawrence Cleary, Kelly Roney, Maged Costantine

Research output: Contribution to journalReview articlepeer-review

15 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)523-527
Number of pages5
JournalSeminars in Perinatology
Issue number8
StatePublished - Dec 1 2014
Externally publishedYes


  • Maternal mortality
  • Preeclampsia
  • Prevention of preeclampsia
  • Statins in pregnancy

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynecology


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