Paroxetine and fluoxetine in pregnancy: a prospective, multicentre, controlled, observational study

Abstract

AIMS: Recent studies have suggested a possible association between maternal use of selective serotonin reuptake inhibitors (SSRIs) in early pregnancy and cardiovascular anomalies. The aim of the present study was to evaluate the teratogenic risk of paroxetine and fluoxetine.\ud \ud METHODS: This multicentre, prospective, controlled study evaluated the rate of major congenital anomalies after first-trimester gestational exposure to paroxetine, fluoxetine or nonteratogens.\ud \ud RESULTS: We followed up 410 paroxetine, 314 fluoxetine first-trimester exposed pregnancies and 1467 controls. After exclusion of genetic and cytogenetic anomalies, there was a higher rate of major anomalies in the SSRI groups compared with the controls [paroxetine 18/348 (5.2%), fluoxetine 12/253 (4.7%) and controls 34/1359 (2.5%)]. The main risk applied to cardiovascular anomalies [paroxetine 7/348 (2.0%), crude odds ratio (OR) 3.47, 95% confidence interval (CI) 1.13, 10.58; fluoxetine 7/253 (2.8%), crude OR, 4.81 95% CI 1.56, 14.71; and controls 8/1359 (0.6%)]. On logistic regression analysis only cigarette smoking of >or=10 cigarettes day(-1) and fluoxetine exposure were significant variables for cardiovascular anomalies. The adjusted ORs for paroxetine and fluoxetine were 2.66 (95% CI 0.80, 8.90) and 4.47 (95% CI 1.31, 15.27), respectively.\ud \ud CONCLUSION: This study suggests a possible association between cardiovascular anomalies and first-trimester exposure to fluoxetine

First‐trimester use of paroxetine and congenital heart defects: A population‐based case‐control study

“…In 2005, the manufacturer of paroxetine, a frequently used SSRI, issued a warning that preliminary analyses from safety data showed an increased risk of cardiovascular anomalies after use of paroxetine compared with use of other antidepressants (GlaxoSmithKline Clinical Trial Register, 2005). After this warning, several cohort studies were published on this association, but the results are inconclusive (Cole et al, 2007;Kallen and Otterblad 2007;Diav-Citrin et al, 2008;Merlob et al, 2009;Pedersen et al, 2009). Together, these cohort studies indicate that SSRIs do not have a major teratogenic effect.…”

Antidepressant use during pregnancy: comparison of data obtained from a prescription register and from antenatal care records

“…Some studies are based on cohorts of exposed women, often obtained from Teratology Information Services (e.g., antidepressant studies [2][3][4]). Such studies are usually limited in size and have therefore little power to detect anything but very strong effects of the drug.…”

Pharmacological safety during pregnancy: the principles of teratogenesis and teratogenicity of drugs

“…[102]. Также предполагается связь между воздействием флуоксетина в первом триместре и развитием ВПС [103]. Однако, другие СИОЗС, включающие сертралин, цитало-прам и эсциталопрам, не оказывали подобных эффек-тов [104].…”