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Studies reporting major malformations with first trimester exposure to paroxetine were included. Potentially relevant articles were assessed and relevant data extracted to calculate risk estimates. Outcomes included any major malformations and major cardiac malformations. Pooled odds ratios and 95% confidence intervals were calculated using random\u2010effects models.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twenty\u2010three studies were included. Compared with non\u2010exposure to paroxetine, first trimester use of paroxetine was associated with an increased risk of any major congenital malformations combined (pooled OR 1.23, 95% CI 1.10, 1.38; <jats:italic>n<\/jats:italic>\u00a0=\u00a015 studies), major cardiac malformations (pooled OR 1.28, 95% CI 1.11, 1.47; <jats:italic>n<\/jats:italic>\u00a0=\u00a018 studies), specifically bulbus cordis anomalies and anomalies of cardiac septal closure (pooled OR 1.42, 95% CI 1.07, 1.89; <jats:italic>n<\/jats:italic>\u00a0=\u00a08 studies), atrial septal defects (pooled OR 2.38, 95% CI 1.14, 4.97; <jats:italic>n<\/jats:italic>\u00a0=\u00a04 studies) and right ventricular outflow track defect (pooled OR 2.29, 95% CI 1.06, 4.93; <jats:italic>n<\/jats:italic>\u00a0=\u00a04 studies). Although the estimates varied depending on the comparator group, study design and malformation detection period, a trend towards increased risk was observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Paroxetine use during the first trimester of pregnancy is associated with an increased risk of any major congenital malformations and cardiac malformations. The increase in risk is not dependent on the study method or population.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.12849","type":"journal-article","created":{"date-parts":[[2015,11,27]],"date-time":"2015-11-27T14:24:40Z","timestamp":1448634280000},"page":"589-604","source":"Crossref","is-referenced-by-count":92,"title":["The risk of major cardiac malformations associated with paroxetine use during the first trimester of pregnancy: a systematic review and meta\u2010analysis"],"prefix":"10.1111","volume":"81","author":[{"given":"Anick","family":"B\u00e9rard","sequence":"first","affiliation":[{"name":"Research Center CHU Ste\u2010Justine  Montreal Quebec"},{"name":"Faculty of Pharmacy University of Montreal  Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noha","family":"Iessa","sequence":"additional","affiliation":[{"name":"Research Center CHU Ste\u2010Justine  Montreal Quebec"},{"name":"Faculty of Pharmacy University of Montreal  Montreal Quebec 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