Abstract
Pregnant and breastfeeding women have been rendered therapeutic orphans as they have been historically excluded from clinical trials. Labelling for most approved drugs does not provide information about safety and efficacy during pregnancy. This lack of data is mainly due to ethico-legal challenges that have remained entrenched in the post-diethylstilbestrol and thalidomide era, and that have led to pregnancy being viewed in the clinical trial setting primarily through a pharmacovigilance lens. Policy considerations that encourage and/or require the inclusion of pregnant or lactating women in clinical trials may address the current lack of available information. However, there are additional pragmatic strategies, such the employment of pharmacometric tools and the introduction of innovative clinical trial designs, which could improve knowledge about the safety and efficacy of medication use during pregnancy and lactation. This paper provides a broad overview of the pharmacoepidemiology of drugs used during pregnancy and lactation, and offers recommendations for regulators and researchers in academia and industry to increase the available pharmacokinetic and -dynamic understanding of medication use in pregnancy.
| Original language | English (US) |
|---|---|
| Journal | British Journal of Clinical Pharmacology |
| DOIs | |
| State | Accepted/In press - 2017 |
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Keywords
- Breastfeeding
- Clinical pharmacology
- Drug utilization
- Obstetric
- Pregnancy
ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)
Cite this
Inclusion of pregnant and breastfeeding women in research - efforts and initiatives. / Illamola, Sílvia M.; Bucci-Rechtweg, Christina; Costantine, Maged; Tsilou, Ekaterini; Sherwin, Catherine M.; Zajicek, Anne.
In: British Journal of Clinical Pharmacology, 2017.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Inclusion of pregnant and breastfeeding women in research - efforts and initiatives
AU - Illamola, Sílvia M.
AU - Bucci-Rechtweg, Christina
AU - Costantine, Maged
AU - Tsilou, Ekaterini
AU - Sherwin, Catherine M.
AU - Zajicek, Anne
PY - 2017
Y1 - 2017
N2 - Pregnant and breastfeeding women have been rendered therapeutic orphans as they have been historically excluded from clinical trials. Labelling for most approved drugs does not provide information about safety and efficacy during pregnancy. This lack of data is mainly due to ethico-legal challenges that have remained entrenched in the post-diethylstilbestrol and thalidomide era, and that have led to pregnancy being viewed in the clinical trial setting primarily through a pharmacovigilance lens. Policy considerations that encourage and/or require the inclusion of pregnant or lactating women in clinical trials may address the current lack of available information. However, there are additional pragmatic strategies, such the employment of pharmacometric tools and the introduction of innovative clinical trial designs, which could improve knowledge about the safety and efficacy of medication use during pregnancy and lactation. This paper provides a broad overview of the pharmacoepidemiology of drugs used during pregnancy and lactation, and offers recommendations for regulators and researchers in academia and industry to increase the available pharmacokinetic and -dynamic understanding of medication use in pregnancy.
AB - Pregnant and breastfeeding women have been rendered therapeutic orphans as they have been historically excluded from clinical trials. Labelling for most approved drugs does not provide information about safety and efficacy during pregnancy. This lack of data is mainly due to ethico-legal challenges that have remained entrenched in the post-diethylstilbestrol and thalidomide era, and that have led to pregnancy being viewed in the clinical trial setting primarily through a pharmacovigilance lens. Policy considerations that encourage and/or require the inclusion of pregnant or lactating women in clinical trials may address the current lack of available information. However, there are additional pragmatic strategies, such the employment of pharmacometric tools and the introduction of innovative clinical trial designs, which could improve knowledge about the safety and efficacy of medication use during pregnancy and lactation. This paper provides a broad overview of the pharmacoepidemiology of drugs used during pregnancy and lactation, and offers recommendations for regulators and researchers in academia and industry to increase the available pharmacokinetic and -dynamic understanding of medication use in pregnancy.
KW - Breastfeeding
KW - Clinical pharmacology
KW - Drug utilization
KW - Obstetric
KW - Pregnancy
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U2 - 10.1111/bcp.13438
DO - 10.1111/bcp.13438
M3 - Article
C2 - 28925019
AN - SCOPUS:85031719908
JO - British Journal of Clinical Pharmacology
JF - British Journal of Clinical Pharmacology
SN - 0306-5251
ER -