Postmarketing surveillance for drug safety in pregnancy: The Organization of Teratology Information Services Project

BACKGROUND Although medications are frequently used during pregnancy, premarketing studies exclude pregnant women, with the result that maternal and fetal risks of medications are largely unknown prior to marketing. METHODS To demonstrate the feasibility of using Teratology Information Services (TIS...

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Published in:Birth defects research. A Clinical and molecular teratology 2004-12, Vol.70 (12), p.944-947
Main Authors: Felix, Robert J., Jones, Kenneth Lyons, Johnson, Kathleen A., McCloskey, Carolyn A., Chambers, Christina D.
Format: Article
Language:English
Subjects:
Abnormalities, Drug-Induced - etiology
Abnormalities, Drug-Induced - prevention & control
Adult
Biological and medical sciences
Data Collection
drug safety
Drug toxicity and drugs side effects treatment
Drug-Related Side Effects and Adverse Reactions
Female
Hotlines
Humans
Information Services
Medical sciences
Miscellaneous (drug allergy, mutagens, teratogens...)
Patient Selection
Pharmacology. Drug treatments
Pregnancy
Pregnancy Complications
pregnancy exposures
Product Surveillance, Postmarketing
Safety
teratogens
Teratogens - toxicity
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Summary:BACKGROUND Although medications are frequently used during pregnancy, premarketing studies exclude pregnant women, with the result that maternal and fetal risks of medications are largely unknown prior to marketing. METHODS To demonstrate the feasibility of using Teratology Information Services (TISs) to identify potential subjects who may participate in postmarketing surveillance studies regarding medications taken during pregnancy, maternal characteristics and pregnancy exposure data routinely collected from callers to member agencies of the Organization of Teratology Information Services (OTIS) were pooled for two one‐month periods. RESULTS A total of 3536 calls inquiring about 7746 different agents were received from pregnant women. Of the 40 medications about which pregnant women most frequently asked, the top two were nonprescription acetaminophen and pseudoephedrine, three were prescription drugs with a U.S. Food and Drug Administration pregnancy label category D designation, and five were prescription antidepressants. CONCLUSIONS TISs are well positioned to prospectively ascertain medication exposures in large numbers of pregnant women and may be an exceptional resource for conducting postmarketing surveillance for the safety of medications taken during pregnancy. Birth Defects Research (Part A) 2004. Published 2004 Wiley‐Liss, Inc.
ISSN:1542-0752
1542-0760
DOI:10.1002/bdra.20090