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Medicines in pregnancy.

Sarah Je Stock1, Jane E Norman2,3

  • 1Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Nine Edinburgh BioQuarter, 9 Little France Road, Edinburgh, EH16 4UX, UK.

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Summary
This summary is machine-generated.

Medication use during pregnancy lacks safety data due to exclusion from trials. Increased investment and legislation are needed for safe drug development and use in pregnant women.

Keywords:
Child HealthMaternal HealthMedicinesNewborn HealthPharmacokineticsPharmacovigilancePregnancyPublic Health

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Area of Science:

  • Pharmacology
  • Obstetrics
  • Public Health

Background:

  • Medication use in pregnancy is common, yet significant knowledge gaps exist regarding drug safety, dosage, and long-term effects.
  • Pregnant women are often excluded from clinical trials, leading to a lack of pharmacokinetic and long-term outcome data for many treatments.
  • Existing treatments are frequently old, untested, or prescribed off-label without adequate safety information, posing risks to both mother and child.

Purpose of the Study:

  • To highlight the critical need for improved research and drug development concerning medication use in pregnancy.
  • To address the public health concern of inadequate investment in obstetric drug development and the lack of data on medication safety during pregnancy.

Main Methods:

  • This study is a review and analysis of the current state of research and investment in medication use during pregnancy.
  • It synthesizes existing literature on the exclusion of pregnant women from clinical trials and the consequences of this exclusion.
  • It identifies gaps in knowledge regarding pharmacokinetics, safety, and long-term outcomes of medications used by pregnant individuals.

Main Results:

  • There is a profound lack of investment in developing new medications for obstetric conditions.
  • Pregnant women's exclusion from clinical trials results in minimal information on drug safety, efficacy, and optimal dosing.
  • Current practices often involve using old, untested medications off-label, increasing risks.

Conclusions:

  • Urgent investment and legislative changes are required to include pregnant women in clinical studies.
  • There is a need to capture high-quality data on medication use in pregnancy and encourage the development of new medicinal products for obstetric conditions.
  • Addressing these issues is crucial for improving maternal and child health outcomes globally.