Risks Associated With Selective Serotonin Reuptake Inhibitors in Pregnancy

University of Helsinki, Helsinki, Uusimaa, Finland
Obstetrics and Gynecology (Impact Factor: 5.18). 12/2005; 106(6):1289-96. DOI: 10.1097/01.AOG.0000187302.61812.53
Source: PubMed


To study the effects of selective serotonin reuptake inhibitors (SSRIs) on pregnancy outcome.
We performed a population-based study of women exposed to SSRIs during pregnancy (n = 1782). Data were derived from a national project in Finland, established by 3 governmental organizations. In that project, the Drug Reimbursement Register, the Medical Birth Register, the Register of Congenital Malformations, and the Register of Induced Abortions have been linked. Comparisons were made between women with SSRI purchases to matched controls and between women with purchases in different trimesters. Only singleton pregnancies were included. Primary outcomes were major malformations, preterm birth, small for gestational age, low birth weight, and treatment in neonatal special or intensive care unit. Analyses were based on logistic models.
Major malformations were not more common in infants or fetuses of women with first trimester SSRI purchases (n = 1,398) when compared with controls with no drug purchases (P = .4). Of infants born to mothers with SSRI purchases in the 3rd trimester, 15.7% were treated in special or intensive care unit compared with 11.2% of infants exposed only during the 1st trimester (P = .009, adjusted odds ratio 1.6, 95% confidence interval 1.1-2.2). We found no increased risk of preterm birth (< 37 weeks), birth 32 weeks of gestation or less, small for gestational age, or low birth weight in women with purchases in each trimester or during the 2nd and 3rd trimesters when compared with women with only 1st trimester purchases.
Use of SSRIs during pregnancy is not independently associated with increased risk of adverse perinatal outcome other than need for treatment in neonatal special or intensive care unit.

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    • "Others have documented linear decreases in gestational age associated with higher antidepressant doses used during pregnancy,170 or increased risk of low birth weight associated with high doses of fluoxetine taken throughout pregnancy.102 However, the majority of individual published studies have been negative,51,90,100,127,153,175,179,186–192 and one study documented a possible increase in the risk of large birth weight with the use of TCAs early in pregnancy.87 "
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    ABSTRACT: In pregnant women with major depression, the overarching goal of treatment is to achieve or maintain maternal euthymia, thus limiting both maternal and fetal exposure to the harmful effects of untreated or incompletely treated depression. However, the absence of uniformly effective therapies with guaranteed obstetric and fetal safety makes the treatment of major depression during pregnancy among the most formidable of clinical challenges. Clinicians and patients are still faced with conflicting data and expert opinion regarding the reproductive safety of antidepressants in pregnancy, as well as large gaps in our understanding of the effectiveness of most antidepressants and nonpharmacological alternatives for treating antenatal depression. In this paper, we provide a clinically focused review of the available information on potential maternal and fetal risks of untreated maternal depression during pregnancy, the effectiveness of interventions for maternal depression during pregnancy, and potential obstetric, fetal, and neonatal risks associated with antenatal antidepressant use.
    Full-text · Article · Sep 2014 · Drug, Healthcare and Patient Safety
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    • "Six authors were unable to provide additional information and the data derived from these samples (Kulin et al., 1998; Einarson et al., 2001a; Wen et al., 2006; Wogelius et al., 2006; Davis et al., 2007; Ramos et al., 2008) was included as an undifferentiated SSRI exposure group. One paper (Kallen and Otterblad Olausson, 2007) was excluded because it reported on a study which was the subject of another paper (Reis and Kallen, 2010); one paper (Einarson et al., 2001a) was excluded because it reported a combined sample which was the subject of two previous studies (Pastuszak et al., 1993; Kulin et al., 1998), and one paper (Malm et al., 2005) was excluded because it reported on a study with a subsequent update (Malm et al., 2011). Various other studies that examined SSRI impact on major malformation were excluded because some mothers in the control group were exposed to other antidepressant medications (Costei et al., 2002; Queisser-Luft et al., 2002; Cole et al., 2007), the exposure group was exposed to heterogeneous antidepressant classes (Chun-Fai-Chan et al., 2005; Maschi et al., 2008; Merlob et al., 2009), the reported effect was based on comparisons of early and late exposure (Berard et al., 2007), or the control group was not contemporaneous to the exposure group (Goldstein et al., 1997) (Figure 1). "
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    ABSTRACT: Context:It has been suggested that the commonly prescribed class of antidepressants selective serotonin reuptake inhibitors (SSRIs) are associated with birth defects. However, the teratogenic effect of individual SSRIs has not been previously compared using meta-analysis.Objective:To determine the strength of the association between individual SSRIs and major, minor, and cardiac malformation among infants born to women taking these medications.Data sources:Electronic search of CINAHL, EMBASE, Medline, PsycINFO, and ISI Web of Science using the search terms (SSRI OR antidepressant) AND (obstetric outcome OR malformation OR birth outcome OR teratogen), supplemented by manual searching of published references and requests of primary researchers for unpublished data.Study selection:There were 115 studies identified by electronic search and reviewed in full text, which yielded 16 papers reporting 36 data samples for major malformations, nine papers reporting 26 data samples for cardiac malformations, and four papers reporting seven data samples for minor malformations.Data synthesis:Fluoxetine (OR 1.14, 95% CI 1.01-1.30) and paroxetine (OR 1.29, 95% CI 1.11-1.49) were associated with increased risk of major malformations. Paroxetine was associated with increased risk of cardiac malformations (OR 1.44, 95% CI 1.12-1.86). Sertraline and citalopram were not significantly associated with congenital malformation. Between-sample heterogeneity was low and a range of methodological considerations had no significant impact on effect size. There was little evidence of publication bias.Conclusions:Fluoxetine and paroxetine should be avoided in the first trimester and among those at risk of an unplanned pregnancy.
    Full-text · Article · Jun 2013 · Australian and New Zealand Journal of Psychiatry
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    • "Research dealing with the consumption of antidepressants and subsequent pregnancy outcomes has indicated an increased risk of congenital malformations, and more notably heart defects [10]–[22]. However, the results are conflicting [12], [14], [17]–[19], [23]–[33] and studies including up to a million pregnancies indicate little risk of congenital malformations [12], [17], [19], [31], [32], or the possibility of confounding by indication [34]. On the other hand, studies show a clear association between SSRI use and persistent pulmonary hypertension of the newborn [35], and no association with perinatal mortality [36], [37]. "
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    ABSTRACT: The aim of this study was to assess the prevalence and patterns of exposure to antidepressants before, during and after pregnancy in a cohort including all pregnant women in Denmark between 1997 and 2010. We performed a retrospective cohort study including 912 322 pregnancies. Information was retrieved from the Danish Birth Registry and The Register of Medicinal Product Statistics to identify women redeeming an antidepressant prescription during pregnancy. Exposure periods were based on standard treatment doses and dispensed pack sizes. We identified 19 740 pregnancies exposed to an antidepressant at some point during pregnancy. The rate of exposure increased from 0.2% in 1997 to 3.2% in 2010. We found that the rate of exposure was halved during the first 3 months of pregnancy. In contrast, we describe a clear increase in exposure after pregnancy among pre-delivery treatment-naïve women. In spite of uncertainty concerning antidepressants' safety during pregnancy we find a 16-fold increase in exposure rates between 1997 and 2010. The rates describe a sharp decrease in exposure during pregnancy that is probably caused by physicians' hesitation to prescribe antidepressants and women's fear of unwanted effects on the unborn child. More studies are needed to clarify the consequences of antidepressant discontinuation during pregnancy.
    Full-text · Article · Apr 2013 · PLoS ONE
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