Medications in the first trimester of pregnancy: most common exposures and critical gaps in understanding fetal risk

Phoebe G Thorpe; Suzanne M Gilboa; Sonia Hernandez‐Diaz; Jennifer Lind; Janet D Cragan; Gerald Briggs; Sandra Kweder; Jan M Friedman; Allen A Mitchell; Margaret A Honein; National Birth Defects Prevention Study

doi:10.1002/pds.3495

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Medications in the first trimester of pregnancy: most common exposures and critical gaps in understanding fetal risk

Journal article

Peer reviewed

Medications in the first trimester of pregnancy: most common exposures and critical gaps in understanding fetal risk

Phoebe G Thorpe, Suzanne M Gilboa, Sonia Hernandez‐Diaz, Jennifer Lind, Janet D Cragan, Gerald Briggs, Sandra Kweder, Jan M Friedman, Allen A Mitchell, Margaret A Honein, …

Pharmacoepidemiology and drug safety, Vol.22(9), pp.1013-1018

09/2013

DOI: 10.1002/pds.3495

PMCID: PMC3996804

PMID: 23893932

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https://www.ncbi.nlm.nih.gov/pmc/articles/3996804View

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Abstract

ABSTRACT Purpose To determine which medications are most commonly used by women in the first trimester of pregnancy and identify the critical gaps in information about fetal risk for those medications. Methods Self‐reported first‐trimester medication use was assessed among women delivering liveborn infants without birth defects and serving as control mothers in two large case–control studies of major birth defects. The Teratology Information System (TERIS) expert Advisory Board ratings of quality and quantity of data available to assess fetal risk were reviewed to identify information gaps. Results Responses from 5381 mothers identified 54 different medication components used in the first trimester by at least 0.5% of pregnant women, including 31 prescription and 23 over‐the‐counter medications. The most commonly used prescription medication components reported were progestins from oral contraceptives, amoxicillin, progesterone, albuterol, promethazine, and estrogenic compounds. The most commonly used over‐the‐counter medication components reported were acetaminophen, ibuprofen, docusate, pseudoephedrine, aspirin, and naproxen. Among the 54 most commonly used medications, only two had “Good to Excellent” data available to assess teratogenic risk in humans, based on the TERIS review. Conclusions For most medications commonly used in pregnancy, there are insufficient data available to characterize the fetal risk fully, limiting the opportunity for informed clinical decisions about the best management of acute and chronic disorders during pregnancy. Future research efforts should be directed at these critical knowledge gaps. Copyright © 2013 John Wiley & Sons, Ltd.

Pregnancy

fetal risk

medication

pharmacoepidemiology

teratogen

Details

Title: Subtitle: Medications in the first trimester of pregnancy: most common exposures and critical gaps in understanding fetal risk
Creators: Phoebe G Thorpe - Centers for Disease Control and Prevention
Suzanne M Gilboa - Centers for Disease Control and Prevention
Sonia Hernandez‐Diaz - Harvard University School of Public Health
Jennifer Lind - Centers for Disease Control and Prevention
Janet D Cragan - Centers for Disease Control and Prevention
Gerald Briggs - Washington State University
Sandra Kweder - Center for Drug Evaluation and Research, US Food and Drug Administration
Jan M Friedman - University of British Columbia
Allen A Mitchell - Boston University
Margaret A Honein - Centers for Disease Control and Prevention
National Birth Defects Prevention Study
Contributors: Paul A Romitti (Contributor) - University of Iowa, Epidemiology
Resource Type: Journal article
Publication Details: Pharmacoepidemiology and drug safety, Vol.22(9), pp.1013-1018
DOI: 10.1002/pds.3495
PMID: 23893932
PMCID: PMC3996804
NLM abbreviation: Pharmacoepidemiol Drug Saf
ISSN: 1053-8569
eISSN: 1099-1557
Number of pages: 6
Language: English
Date published: 09/2013
Academic Unit: Epidemiology; Biostatistics
Record Identifier: 9984214955702771

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