Article

Pregnancy Outcome Following Gestational Exposure to Venlafaxine: A Multicenter Prospective Controlled Study

The Motherisk Program, The Hospital for Sick Children, University of Toronto, Ontario, Canada.
American Journal of Psychiatry (Impact Factor: 13.56). 11/2001; 158(10):1728-30. DOI: 10.1176/appi.ajp.158.10.1728
Source: PubMed

ABSTRACT Because there are no studies available on the safety of venlafaxine during pregnancy, the authors' goal in this study was to determine whether venlafaxine increases the risk for major malformations.
Data on 150 women exposed to venlafaxine during pregnancy in seven pregnancy counseling centers were compared with data from studies of pregnant women who 1) received selective serotonin reuptake inhibitor antidepressants (SSRIs) (N=150) and 2) who received nonteratogenic drugs (N=150).
Among the 150 women who were exposed to venlafaxine during pregnancy, 125 had live births, 18 had spontaneous abortions, and seven had therapeutic abortions; two of the babies had major malformations. There were no significant differences between these women and the two comparison groups on any of the measures analyzed.
These results suggest that the use of venlafaxine during pregnancy does not increase the rates of major malformations above the baseline rate of 1%-3%.

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    • "Conflicting results also emerged for the risk of SA . While Nakhai - Pour et al . ( 2010 ) and Kjaersgaard et al . ( 2013 ) observed an increased risk of SA in women treated with VEN , another study did not found such association ( Einarson et al . , 2001 ) . When consid - ering these contradictory results , it should be noted that even the risk of SSRIs in inducing SA still remains to be established ( Santone et al . , 2009 ) ."
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    ABSTRACT: OBJECTIVE: The present study provides a comprehensive review of the existing literature on the safety of serotonin-noradrenaline reuptake inhibitors (SNRIs) in pregnancy and lactation. METHODS: Studies published in English, reporting the use of SNRIs in pregnant and/or breastfeeding women, were identified by searching MEDLINE/Pubmed, PsycINFO, and EMBASE. RESULTS: Twenty-nine studies were included in the review. Altogether, the initial evidence coming from the reviewed studies suggests a lack of association between SNRIs and an increased risk of major congenital malformations. Conversely, exposure to SNRIs seems to be significantly associated with an increased risk of some perinatal complications. No neonatal adverse events emerged, so far, in the few studies concerning the safety of SNRIs during breastfeeding. CONCLUSIONS: Available data suggest that venlafaxine is relatively safe during pregnancy, in particular as far as major malformations are concerned, whereas considering the small number of studies published, no definitive conclusions can be drawn on its safety during breastfeeding. Because of the few studies so far published, the safety of duloxetine during pregnancy and breastfeeding remains to be well established
    Human Psychopharmacology Clinical and Experimental 03/2015; DOI:10.1002/hup.2473. · 1.85 Impact Factor
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    • "Conflicting results also emerged for the risk of SA . While Nakhai - Pour et al . ( 2010 ) and Kjaersgaard et al . ( 2013 ) observed an increased risk of SA in women treated with VEN , another study did not found such association ( Einarson et al . , 2001 ) . When consid - ering these contradictory results , it should be noted that even the risk of SSRIs in inducing SA still remains to be established ( Santone et al . , 2009 ) ."
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    ABSTRACT: The present study provides a comprehensive review of the existing literature on the safety of serotonin-noradrenaline reuptake inhibitors (SNRIs) in pregnancy and lactation. Studies published in English, reporting the use of SNRIs in pregnant and/or breastfeeding women, were identified by searching MEDLINE/Pubmed, PsycINFO, and EMBASE. Twenty-nine studies were included in the review. Altogether, the initial evidence coming from the reviewed studies suggests a lack of association between SNRIs and an increased risk of major congenital malformations. Conversely, exposure to SNRIs seems to be significantly associated with an increased risk of some perinatal complications. No neonatal adverse events emerged, so far, in the few studies concerning the safety of SNRIs during breastfeeding. Available data suggest that venlafaxine is relatively safe during pregnancy, in particular as far as major malformations are concerned, whereas considering the small number of studies published, no definitive conclusions can be drawn on its safety during breastfeeding. Because of the few studies so far published, the safety of duloxetine during pregnancy and breastfeeding remains to be well established. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Human Psychopharmacology Clinical and Experimental 03/2015; 30(3). DOI:10.1002/hup.2473 · 1.85 Impact Factor
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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.
    Australian and New Zealand Journal of Psychiatry 06/2013; 47(11). DOI:10.1177/0004867413492219 · 3.77 Impact Factor
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