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 journalArticle

11 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)523-527
Number of pages5
JournalSeminars in Perinatology
Volume38
Issue number8
DOIs
StatePublished - Dec 1 2014

Fingerprint

Pravastatin
Pre-Eclampsia
Pregnancy
Pharmaceutical Preparations
Mothers
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pregnancy Complications
Clinical Pharmacology
United States Food and Drug Administration
Practice Guidelines
Research
Oxidoreductases
Cardiovascular Diseases
Pharmacokinetics
Cholesterol
Medicine
Morbidity
Safety
Mortality

Keywords

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

ASJC Scopus subject areas

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

Cite this

Challenges of studying drugs in pregnancy for off-label indications : Pravastatin for preeclampsia prevention. / Cleary, Kirsten Lawrence; Roney, Kelly; Costantine, Maged.

In: Seminars in Perinatology, Vol. 38, No. 8, 01.12.2014, p. 523-527.

Research output: Contribution to journalArticle

Cleary, Kirsten Lawrence ; Roney, Kelly ; Costantine, Maged. / Challenges of studying drugs in pregnancy for off-label indications : Pravastatin for preeclampsia prevention. In: Seminars in Perinatology. 2014 ; Vol. 38, No. 8. pp. 523-527.
@article{173b1e52563a4deb9b03fa350d590ecc,
title = "Challenges of studying drugs in pregnancy for off-label indications: Pravastatin for preeclampsia prevention",
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.",
keywords = "Maternal mortality, Preeclampsia, Prevention of preeclampsia, Statins in pregnancy",
author = "Cleary, {Kirsten Lawrence} and Kelly Roney and Maged Costantine",
year = "2014",
month = "12",
day = "1",
doi = "10.1053/j.semperi.2014.08.019",
language = "English (US)",
volume = "38",
pages = "523--527",
journal = "Seminars in Perinatology",
issn = "0146-0005",
publisher = "W.B. Saunders Ltd",
number = "8",

}

TY - JOUR

T1 - Challenges of studying drugs in pregnancy for off-label indications

T2 - Pravastatin for preeclampsia prevention

AU - Cleary, Kirsten Lawrence

AU - Roney, Kelly

AU - Costantine, Maged

PY - 2014/12/1

Y1 - 2014/12/1

N2 - 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.

AB - 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.

KW - Maternal mortality

KW - Preeclampsia

KW - Prevention of preeclampsia

KW - Statins in pregnancy

UR - http://www.scopus.com/inward/record.url?scp=84918577732&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84918577732&partnerID=8YFLogxK

U2 - 10.1053/j.semperi.2014.08.019

DO - 10.1053/j.semperi.2014.08.019

M3 - Article

VL - 38

SP - 523

EP - 527

JO - Seminars in Perinatology

JF - Seminars in Perinatology

SN - 0146-0005

IS - 8

ER -