Antidepressant drug choice in pregnancy is a complex problem especially for new drugs. Among 590 cases exposed to drugs during pregnancy who were followed by our center, 21 cases used newer antidepressants, i.e., venlafaxine, mirtazapine, nefazodone. We present the gestational findings and fetal outcomes of these cases. Ten cases had used venlafaxine, one case had used both venlafaxine and mirtazapine, eight had used mirtazapine alone or with some other drugs and two had used nefazodone, in the first trimester. Of the 21 cases, 17 (80.9%) had healthy babies, 3 (14.3%) decided to terminate the pregnancy, and 1 (4.8%) spontaneous abortion was observed in a case exposed to mirtazapine, alprazolam, diazepam and trifluoperazine. All obstetrical findings were normal during the pregnancy of each case. No congenital abnormality and developmental problem was observed in the babies followed up for 12 months. The aim of the present study is to contribute the data to the limited knowledge available in the literature regarding human pregnancy.
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"Few epidemiologic studies have investigated the use of venlafaxine during pregnancy and birth defects. Because of small numbers, some studies have grouped exposure to venlafaxine with exposure to SSRIs (citalopram, fluoxetine, paroxetine, and sertraline) or other newer antidepressants, which does not allow for examination of specific effects of venlafaxine exposure separate from these other antidepressant medications (Yaris et al., 2004; Källén, 2004b; Ferreira et al., 2007; Lennestal and Källén, 2007; Einarson et al., 2009; Wichman et al., 2009; Reis and Källén, 2010). In general, these studies found no associations between major malformations and SNRI medications as a group. "
[Show abstract][Hide abstract]ABSTRACT: Few epidemiologic studies have investigated the use of venlafaxine (Effexor XR capsules, Product Monograph, Wyeth, Montreal, Canada), an antidepressant used to treat major depression and anxiety disorders in adults, during pregnancy. Our objective was to determine whether use of venlafaxine during pregnancy is associated with specific birth defects.
We used data from the National Birth Defects Prevention Study (NBDPS), a population-based, case-control study in the United States. Our analysis included mothers with pregnancies affected by one of 30 selected birth defects (cases) and babies without birth defects (controls) with estimated dates of delivery between 1997 and 2007. Exposure was any reported use of venlafaxine from 1 month preconception through the third month of pregnancy. We calculated adjusted odds ratios (aORs) and 95% Fisher Exact confidence intervals (CIs) for 24 birth defect groups for which at least 400 case mothers were interviewed. Our adjusted analyses controlled for maternal age and race/ethnicity.
Among the 27,045 NBDPS participants who met inclusion criteria, 0.17% (14/8002) of control mothers and 0.40% (77/19,043) of case mothers reported any use of venlafaxine from 1 month preconception through the third month of pregnancy. Statistically significant associations were found for anencephaly, atrial septal defect (ASD) secundum, or ASD not otherwise specified, coarctation of the aorta, cleft palate, and gastroschisis.
Our data suggest associations between periconceptional use of venlafaxine and some birth defects. However, sample sizes were small, CIs were wide, and additional studies are needed to confirm these results. Birth Defects Research (Part A), 2013.
Full-text · Article · Jan 2013 · Birth Defects Research Part A Clinical and Molecular Teratology
"The above results suggest that the mirtazapine possess feto-toxic effects. These observations are in congruence with earlier studies    , which reports the spontaneous abortions and major malformation associated with mirtazapine exposure. "
[Show abstract][Hide abstract]ABSTRACT: Mirtazapine is an often used antidepressant drug; however insufficient information is available regarding its safety during pregnancy. Therefore, this work was initiated to study the effect of prenatal exposure of mirtazapine on postnatal developments of rats. The study was conducted on pregnant rats to observe the safety profile of mirtazapine in comparison to control. The percentage weight gain, gestation period and litter size of the rats treated with double therapeutic dose (DTD) was significantly lower than the rats treated with therapeutic dose (TD) and rats of control group. However the litter size of the TD treated rats was also found smaller than the control. The offspring were examined through battery of test in order to evaluate their developmental neurotoxicity. The test includes the assessment of postnatal growth, reflex ontogeny, neuromotor abilities, activity level, emotional reactivity and learning ability. The DTD exposure negatively affected on overall growth of pups in comparison to TD exposed pups and control group. Further, the amine concentration in brain was also found significantly lower in DTD exposed pups. Therefore, this study reveals that the treatment of pregnant rats with TD and DTD decreases their litter size. In addition the prenatal exposure of DTD of mirtazapine negatively affects on neurodevelopment of rats.
Full-text · Article · Sep 2010 · Scientia Pharmaceutica
"The literature search identified 21 papers. Seven were excluded because did not report data concerning SA (De Las Cuevas et al., 2007; Ericson et al., 1999; Malm et al., 2005; Simon et al., 2002 ; Suri et al., 2004; 2007; Wen et al., 2006), and one (Yaris et al., 2004) because it was an uncontrolled study. Three studies (Edwards et al., 1994; McHelatton et al., 1996; Nulman et al., 1997), focusing on the risk of SA, but considering as control group only pregnant women exposed to ADs, were also excluded. "
[Show abstract][Hide abstract]ABSTRACT: To review studies conducted to establish the risk of spontaneous abortion (SA) in women exposed to antidepressant drugs (ADs) during early pregnancy.
By using different search terms, PubMed, Toxline, EMBASE, PsychINFO, and the Cochrane library databases were searched from January 1980 to March 2008, to identify studies assessing the risk of SA in women exposed to different classes of ADs during the first trimester of pregnancy.
Ten studies over 21 identified were selected for the analysis. All were performed prospectively and included as control group unexposed women, or exposed to non-teratogenic drugs or to placebo. In seven studies a depressive episode was specified as the reason for which the drug was prescribed, while the time of exposure was in nine.
Only three studies over ten selected reported a significant association between an increased rate of SAs and early pregnancy exposure to some ADs. Many methodological flaws in the study design were found in all studies considered. Given this background and a lack of strong evidence on this issue, further prospective and better designed studies are needed to assess the risk of SA in pregnant women exposed to ADs against the risk of an untreated maternal depression.