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: 12.3). 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: 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.
    Full-text · Article · Mar 2015 · Human Psychopharmacology Clinical and Experimental
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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
    Full-text · Article · Mar 2015 · Human Psychopharmacology Clinical and Experimental
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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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