A review of pregnancy and lactation postmarketing studies required by the FDA
J Krastein, L Sahin, L Yao - Pharmacoepidemiology and Drug …, 2023 - Wiley Online Library
Since pregnant and lactating women have historically been excluded from drug
development trials, safety studies need to be conducted postapproval. This study evaluated …
development trials, safety studies need to be conducted postapproval. This study evaluated …
Guide for drug selection during pregnancy and lactation: what pharmacists need to know for current practice
BL Griffin, RH Stone, SY El-Ibiary… - Annals of …, 2018 - journals.sagepub.com
Objective: To provide guidance for clinicians on risk assessment of medication use during
pregnancy and lactation. Data Sources: Authors completed PubMed searches to identify …
pregnancy and lactation. Data Sources: Authors completed PubMed searches to identify …
Safety and efficacy of drugs in pregnancy.
D Knoppert - Journal of Population Therapeutics and Clinical …, 2011 - europepmc.org
Although most drugs are used to treat chronic or pregnancy-induced conditions during
pregnancy and lactation, very few are studied in pregnant or breastfeeding women. The …
pregnancy and lactation, very few are studied in pregnant or breastfeeding women. The …
Improving safe and effective use of drugs in pregnancy and lactation: workshop summary
LE Riley, AG Cahill, R Beigi, R Savich… - American journal of …, 2017 - thieme-connect.com
In February 2015, given high rates of use of medications by pregnant women and the
relative lack of data on safety and efficacy of many drugs utilized in pregnancy, the Eunice …
relative lack of data on safety and efficacy of many drugs utilized in pregnancy, the Eunice …
Medication use in early pregnancy‐prevalence and determinants of use in a prospective cohort of women
BJ Cleary, H Butt, JD Strawbridge… - … and drug safety, 2010 - Wiley Online Library
Purpose To examine the extent, nature and determinants of medication use in early
pregnancy. Methods We reviewed early pregnancy medication use, as reported to a midwife …
pregnancy. Methods We reviewed early pregnancy medication use, as reported to a midwife …
Safety profile of medication used during pregnancy: results of a multinational European study
JN Trønnes, A Lupattelli… - … and drug safety, 2017 - Wiley Online Library
Purpose The present study describes the safety profile of medications used during
pregnancy across European countries and examines maternal factors associated with the …
pregnancy across European countries and examines maternal factors associated with the …
Call to action: Harmonization of pharmacovigilance regulations for post‐marketing pregnancy and breastfeeding safety studies
A Alexe, O Eisele, MFS Fernandes… - British Journal of …, 2024 - Wiley Online Library
Globally, more than 200 million women become pregnant each year, most of whom receive
medications despite limited information on their safe use during pregnancy. The paucity of …
medications despite limited information on their safe use during pregnancy. The paucity of …
Inclusion of pregnant and breastfeeding women in research–efforts and initiatives
SM Illamola, C Bucci‐Rechtweg… - British Journal of …, 2018 - Wiley Online Library
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 …
been historically excluded from clinical trials. Labelling for most approved drugs does not …
Medications in pregnancy and lactation
CS Buhimschi, CP Weiner - Management of High‐Risk …, 2007 - Wiley Online Library
Almost 100% of pregnant women are exposed to medications during pregnancy [1]. While
thousands of pregnant and breastfeeding women ingest either a prescribed or over …
thousands of pregnant and breastfeeding women ingest either a prescribed or over …
Should pregnant women be included in phase IV clinical drug trials?
GG Briggs, JE Polifka, KL Wisner, E Gervais… - American journal of …, 2015 - Elsevier
Relatively few drugs, especially those recently approved by the US Food and Drug
Administration, have published human pregnancy experience. Although all drugs contain …
Administration, have published human pregnancy experience. Although all drugs contain …