ArticleBritish journal of clinical pharmacology2016
EUROmediCAT signal detection: an evaluation of selected congenital anomaly-medication associations.
Article in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed, 21 citations in OpenAlex.
- Case-malformed signal detection and prioritisation using EUROmediCAT data for pharmacovigilance in pregnancy.British journal of clinical pharmacology · 2026Article
- The EUROmediCAT Network and Databases: A Resource for Pharmacovigilance in Pregnancy.Pharmacoepidemiology and drug safety · 2026Article
- Investigating the Benefit-Risk Profile of Drugs: From Spontaneous Reporting Systems to Real-World Data for Pharmacovigilance.Methods in molecular biology (Clifton, N.J.) · 2025Article
- The changing epidemiology of syndactyly in Chinese newborns: a nationwide surveillance-based study.BMC pregnancy and childbirth · 2023Article
- Article
- Endocrine disrupting chemicals and reproductive disorders in women, men, and animal models.Advances in pharmacology (San Diego, Calif.) · 2021Article
- Prevalence and safety of prescription medicine use during pregnancy in the Republic of Suriname in the year 2017: a pharmacoepidemiological analysis.Advances in pharmacoepidemiology & drug safety · 2021Article
- Endocrine disrupting chemicals in the pathogenesis of hypospadias; developmental and toxicological perspectives.Current research in toxicology · 2021Review
- Spatial analysis of hypospadias cases in northern France: taking clinical data into account.BMC pediatrics · 2020Article
- Exposure to Infliximab During Pregnancy: Post-Marketing Experience.Drug safety · 2020Article
- Risk of gastroschisis with maternal genitourinary infections: the US National birth defects prevention study 1997-2011.BMJ open · 2019Article
- Identifying signals of potentially harmful medications in pregnancy: use of the double false discovery rate method to adjust for multiple testing.British journal of clinical pharmacology · 2019Article
- Aim and Design of pREGnant, the Dutch Pregnancy Drug Register.Drug safety · 2019Article
- Pharmacologic and Environmental Endocrine Disruptors in the Pathogenesis of Hypospadias: a Review.Current environmental health reports · 2018Review
- EUROmediCAT signal detection: an evaluation of selected congenital anomaly-medication associations.British journal of clinical pharmacology · 2016Article
- EUROmediCAT signal detection: a systematic method for identifying potential teratogenic medication.British journal of clinical pharmacology · 2016Article
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Authors and funding
20 authors at 16 institutions in 15 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo evaluate congenital anomaly (CA)-medication exposure associations produced by the new EUROmediCAT signal detection system and determine which require further investigation.
methodsData 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.
resultsThirteen 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.
conclusionSignals 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.
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