EUROmediCAT signal detection: an evaluation of selected congenital anomaly-medication associations.

Details

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State: Public
Version: Final published version
Serval ID
serval:BIB_868199571B50
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
EUROmediCAT signal detection: an evaluation of selected congenital anomaly-medication associations.
Journal
British journal of clinical pharmacology
Author(s)
Given J.E., Loane M., Luteijn J.M., Morris J.K., de Jong van den Berg L.T., Garne E., Addor M.C., Barisic I., de Walle H., Gatt M., Klungsoyr K., Khoshnood B., Latos-Bielenska A., Nelen V., Neville A.J., O'Mahony M., Pierini A., Tucker D., Wiesel A., Dolk H.
ISSN
1365-2125 (Electronic)
ISSN-L
0306-5251
Publication state
Published
Issued date
10/2016
Peer-reviewed
Oui
Volume
82
Number
4
Pages
1094-1109
Language
english
Notes
Publication types: Evaluation Studies ; Journal Article
Publication Status: ppublish
Abstract
To evaluate congenital anomaly (CA)-medication exposure associations produced by the new EUROmediCAT signal detection system and determine which require further investigation.
Data from 15 EUROCAT registries (1995-2011) with medication exposures at the chemical substance (5th level of Anatomic Therapeutic Chemical classification) and chemical subgroup (4th level) were analysed using a 50% false detection rate. After excluding antiepileptics, antidiabetics, antiasthmatics and SSRIs/psycholeptics already under investigation, 27 associations were evaluated. If evidence for a signal persisted after data validation, a literature review was conducted for prior evidence of human teratogenicity.
Thirteen out of 27 CA-medication exposure signals, based on 389 exposed cases, passed data validation. There was some prior evidence in the literature to support six signals (gastroschisis and levonorgestrel/ethinylestradiol (OR 4.10, 95% CI 1.70-8.53; congenital heart disease/pulmonary valve stenosis and nucleoside/tide reverse transcriptase inhibitors (OR 5.01, 95% CI 1.99-14.20/OR 28.20, 95% CI 4.63-122.24); complete absence of a limb and pregnen (4) derivatives (OR 6.60, 95% CI 1.70-22.93); hypospadias and pregnadien derivatives (OR 1.40, 95% CI 1.10-1.76); hypospadias and synthetic ovulation stimulants (OR 1.89, 95% CI 1.28-2.70). Antipropulsives produced a signal for syndactyly while the literature revealed a signal for hypospadias. There was no prior evidence to support the remaining six signals involving the ordinary salt combinations, propulsives, bulk-forming laxatives, hydrazinophthalazine derivatives, gonadotropin releasing hormone analogues and selective serotonin agonists.
Signals which strengthened prior evidence should be prioritized for further investigation, and independent evidence sought to confirm the remaining signals. Some chance associations are expected and confounding by indication is possible.

Keywords
Abnormalities, Drug-Induced/epidemiology, Adverse Drug Reaction Reporting Systems/statistics & numerical data, Congenital Abnormalities/epidemiology, Europe/epidemiology, Female, Humans, Infant, Newborn, Pregnancy, Registries, congenital anomalies, drug-induced anomalies, pharmacoepidemiology, pharmacovigilance, pregnancy, signal evaluation
Pubmed
Web of science
Create date
02/12/2016 11:42
Last modification date
20/08/2019 14:45
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