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

Pharmacoepidemiology and Drug Safety - Tập 22 Số 9 - Trang 1013-1018 - 2013
Phoebe Thorpe1, Suzanne M. Gilboa1, Sonia Hernández–Dı́az2, Jennifer N. Lind1, Janet D. Cragan1, Gerald G. Briggs3,4,5, Sandra L. Kweder6, Jan M. Friedman7, Allen A. Mitchell8, Margaret A. Honein1
1Division of Birth Defects and Developmental Disabilities Centers for Disease Control and Prevention Atlanta GA USA
2Harvard University, School of Public Health, Boston, MA, USA
3University of California San Francisco, CA. USA
4University of Southern California, Los Angeles, CA USA
5Washington State University, Spokane, WA, USA
6Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA
7University of British Columbia, Vancouver, British Columbia, Canada
8Slone Epidemiology Center, Boston University, Boston, MA, USA

Tóm tắt

ABSTRACTPurposeTo 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.MethodsSelf‐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.ResultsResponses 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.ConclusionsFor 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.

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Thông tin xuất bản

Pharmacoepidemiology and Drug Safety

Tập 22 Số 9

1013-1018

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