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

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dc.contributor.authorGiven, Joanne E.
dc.contributor.authorLoane, Maria
dc.contributor.authorLuteijn, Johannes M.
dc.contributor.authorMorris, Joan K.
dc.contributor.authorde Jong van den Berg, Lolkje T.W.
dc.contributor.authorGarne, Ester
dc.contributor.authorAddor, Marie-Claude
dc.contributor.authorBarisic, Ingeborg
dc.contributor.authorde Walle, Hermien
dc.contributor.authorGatt, Miriam
dc.contributor.authorKlungsoyr, Kari
dc.contributor.authorKhoshnood, Babak
dc.contributor.authorLatos-Bielenska, Anna
dc.contributor.authorNelen, Vera
dc.contributor.authorNeville, Amanda J.
dc.contributor.authorO'Mahony, Mary
dc.contributor.authorPierini, Anna
dc.contributor.authorTucker, David
dc.contributor.authorWiesel, Awi
dc.contributor.authorDolk, Helen
dc.contributor.funderSeventh Framework Programmeen
dc.contributor.funderEuropean Commissionen
dc.contributor.funderNational Research Councilen
dc.contributor.funderGlaxoSmithKlineen
dc.contributor.funderInstitute of Clinical Physiologyen
dc.date.accessioned2019-11-26T12:21:32Z
dc.date.available2019-11-26T12:21:32Z
dc.date.issued2016-09-09
dc.description.abstractAims: 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
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationGiven, J. E., Loane, M., Luteijn, J. M., Morris, J. K., de Jong van den Berg, L. T. W., 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. and Dolk, H. (2016) 'EUROmediCAT signal detection: an evaluation of selected congenital anomaly-medication associations', British Journal of Clinical Pharmacology, 82(4), pp. 1094-1109. doi: 10.1111/bcp.12947en
dc.identifier.doi10.1111/bcp.12947en
dc.identifier.eissn1365-2125
dc.identifier.endpage1109en
dc.identifier.issn0306-5251
dc.identifier.issued4en
dc.identifier.journaltitleBritish Journal of Clinical Pharmacologyen
dc.identifier.startpage1094en
dc.identifier.urihttps://hdl.handle.net/10468/9253
dc.identifier.volume82en
dc.language.isoenen
dc.publisherBritish Pharmacology Societyen
dc.relation.projectinfo:eu-repo/grantAgreement/EC/FP7::SP1::HEALTH/260598/EU/EUROmediCAT: Safety of Medication use in Pregnancy in Relation to Risk of Congenital Malformations/EUROMEDICATen
dc.rights© 2016, The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of The British Pharmacological Society 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.en
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/en
dc.subjectCongenital anomaliesen
dc.subjectDrug-induced anomaliesen
dc.subjectPharmacoepidemiologyen
dc.subjectPharmacovigilanceen
dc.subjectPregnancyen
dc.subjectSignal evaluationen
dc.subject~Medicine - Journal Articles~en
dc.titleEUROmediCAT signal detection: An evaluation of selected congenital anomaly-medication associationsen
dc.typeArticle (peer-reviewed)en
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