dc.contributor.author | Given, JE | en_US |
dc.contributor.author | Loane, M | en_US |
dc.contributor.author | Luteijn, JM | en_US |
dc.contributor.author | Morris, JK | en_US |
dc.contributor.author | de Jong van den Berg, LTW | en_US |
dc.contributor.author | Garne, E | en_US |
dc.contributor.author | Addor, M-C | en_US |
dc.contributor.author | Barisic, I | en_US |
dc.contributor.author | de Walle, H | en_US |
dc.contributor.author | Gatt, M | en_US |
dc.contributor.author | Klungsoyr, K | en_US |
dc.contributor.author | Khoshnood, B | en_US |
dc.contributor.author | Latos-Bielenska, A | en_US |
dc.contributor.author | Nelen, V | en_US |
dc.contributor.author | Neville, AJ | en_US |
dc.contributor.author | O'Mahony, M | en_US |
dc.contributor.author | Pierini, A | en_US |
dc.contributor.author | Tucker, D | en_US |
dc.contributor.author | Wiesel, A | en_US |
dc.contributor.author | Dolk, H | en_US |
dc.date.accessioned | 2018-06-26T10:13:25Z | |
dc.date.available | 2016-03-23 | en_US |
dc.date.issued | 2016-10 | en_US |
dc.date.submitted | 2018-03-11T08:30:15.052Z | |
dc.identifier.uri | http://qmro.qmul.ac.uk/xmlui/handle/123456789/40403 | |
dc.description.abstract | AIMS: To evaluate congenital anomaly (CA)-medication exposure associations produced by the new EUROmediCAT signal detection system and determine which require further investigation. METHODS: 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. RESULTS: 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. CONCLUSION: 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. | en_US |
dc.description.sponsorship | European Commission under the 7th Framework Program (grant agreement HEALTH‐F5‐2011‐260598). | en_US |
dc.format.extent | 1094 - 1109 | en_US |
dc.language | eng | en_US |
dc.language.iso | en | en_US |
dc.relation.ispartof | Br J Clin Pharmacol | en_US |
dc.rights | This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. | |
dc.subject | congenital anomalies | en_US |
dc.subject | drug-induced anomalies | en_US |
dc.subject | pharmacoepidemiology | en_US |
dc.subject | pharmacovigilance | en_US |
dc.subject | pregnancy | en_US |
dc.subject | signal evaluation | en_US |
dc.subject | Abnormalities, Drug-Induced | en_US |
dc.subject | Adverse Drug Reaction Reporting Systems | en_US |
dc.subject | Congenital Abnormalities | en_US |
dc.subject | Europe | en_US |
dc.subject | Female | en_US |
dc.subject | Humans | en_US |
dc.subject | Infant, Newborn | en_US |
dc.subject | Pregnancy | en_US |
dc.subject | Registries | en_US |
dc.title | EUROmediCAT signal detection: an evaluation of selected congenital anomaly-medication associations. | en_US |
dc.type | Article | |
dc.rights.holder | © 2016 The Authors. | |
dc.identifier.doi | 10.1111/bcp.12947 | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/27028286 | en_US |
pubs.issue | 4 | en_US |
pubs.notes | Not known | en_US |
pubs.publication-status | Published | en_US |
pubs.volume | 82 | en_US |
dcterms.dateAccepted | 2016-03-23 | en_US |