Paroxetine in the first trimester and the prevalence of congenital malformations

Cole, J. Alexander; Ephross, Sara A.; Cosmatos, Irene; Walker, Alexander M.

doi:10.1002/pds.1463

Cited by 146 publications

(96 citation statements)

References 12 publications

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“…4 In 2005, based on early results of two epidemiologic studies, the US Food and Drug Administration (FDA) warned healthcare professionals that early prenatal exposure to paroxetine may increase the risk of congenital cardiac malformations and reclassified it to pregnancy category D. 5 Most malformations in the early reports leading to the FDA warning were septal defects. Since then, several studies have evaluated the teratogenicity of SSRIs and other antidepressants [6][7][8][9][10][11][12][13][14][15][16][17][18][19] , but considerable controversy remains as to whether this is a "serious concern or much ado about little" as noted in an editorial published with two of the reports. 13,1420 Existing studies have reported different associations, often in the context of multiple comparisons.…”

Section: Conclusion-resultsmentioning

confidence: 99%

Antidepressant Use in Pregnancy and the Risk for Cardiac Defects

Huybrechts

Palmsten

Avorn

et al. 2014

Obstetrical &Amp; Gynecological Survey

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Background-There is controversy regarding whether the use of selective serotonin reuptake inhibitors (SSRIs) and other antidepressants in pregnancy is associated with increased risks for congenital cardiac defects. In particular, concerns exist about a possible association between paroxetine and right ventricular outflow tract obstruction (RVOTO), and between sertraline and ventricular septal defects (VSD).

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Section: Conclusion-resultsmentioning

confidence: 99%

Antidepressant Use in Pregnancy and the Risk for Cardiac Defects

Huybrechts

Palmsten

Avorn

et al. 2014

Obstetrical &Amp; Gynecological Survey

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“…Several studies [18][19][20][21][22] have shown an increased risk of VSDs in neonates exposed to paroxetine during the first trimester. This finding led the US Food and Drug Administration to advise women to avoid paroxetine during pregnancy if possible and to change pregnancy labeling from a category C to D. Paroxetine is the only SSRI whose pregnancy category labeling has changed.…”

Section: Discussionmentioning

confidence: 99%

Congenital Heart Disease Associated With Selective Serotonin Reuptake Inhibitor Use During Pregnancy

Wichman

Moore

Lang

et al. 2009

Mayo Clinic Proceedings

144

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OBJECTIVE:To determine the risk of congenital cardiac abnormalities associated with use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy. PATIENTS AND METHODS:We conducted a retrospective review of the medical records of all pregnant women presenting at Mayo Clinic's site in Rochester, MN, from January 1, 1993, to July 15, 2005, and identified 25,214 deliveries. A total of 808 mothers were treated with SSRIs at some point during their pregnancy. We reviewed the medical records of the newborns exposed to SSRIs during pregnancy to analyze their outcomes, specifically for congenital heart disease and persistent pulmonary hypertension of the newborn. RESULTS:Of the study patients, 808 (3.2%) took an SSRI at some point during the antenatal period. Of the 25,214 deliveries, 208 newborns (0.8%) were diagnosed as having congenital heart disease. Of the 808 women exposed to SSRI during pregnancy, 3 (0.4%) had congenital heart disease compared with 205 (0.8%) of the 24,406 women not exposed to an SSRI (P=.23). Of the total number of deliveries, 16 newborns were diagnosed as having persistent pulmonary hypertension of the newborn, none of whom had exposure to SSRIs (P>.99). © 2009 Mayo Foundation for Medical Education and ResearchR ecent data indicate that approximately 10% to 15% of women will have depression at some point during pregnancy or the postpartum period. 1,2 Untreated depression during pregnancy may lead to poor outcomes, including low birth weight, preterm delivery, or lower Apgar scores; poor prenatal care; failure to recognize or report signs of labor; and an increased risk of fetal abuse, neonaticide, or suicide. 1,2 Selective serotonin reuptake inhibitors (SSRIs) are the first-line pharmacotherapy for depression, and SSRI use during pregnancy has been well documented.Overall, data regarding the use of SSRIs during pregnancy have been reassuring. Most studies 3-9 have reported relatively consistent findings on the adverse effects of SSRI use during pregnancy, which include neonatal withdrawal syndrome, low birth weight, and preterm birth. Many studies 10-12 have indicated no major fetal malformations higher than the baseline population risk of 1% to 3% with use of SSRIs during pregnancy. One study 13 has indicated increased risks for specific defects, whereas another study 14 noted an association between overall SSRI use during pregnancy and 3 distinct types of birth defects.Congenital heart disease (CHD) is recognized in approximately 0.4% to 1% of all live births, 15-17 and several studies have suggested that use of an SSRI, particularly paroxetine, may be associated with an increased risk of CHD. In particular, ventricular septal defects (VSDs) have been associated with use of paroxetine during the first trimester, 18-22 although a recent meta-analysis 23 that reviewed both previously published and unpublished data did not confirm this association. One report 20 showed a dose response in neonates exposed to paroxetine during the first trimester; infants exposed to paroxetine at dosag...

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“…Cole et al (2007) observed an increased risk for all malformations after the use of paroxetine (OR, 1.76; 95% CI, 1.18-2.64), but not for cardiovascular malformations (OR, 1.46; 95% CI, 0.74-2.88); they used an administrative database from a health care insurer and compared malformation rates with a cohort of mothers using other antidepressants. Only liveborn children with malformations were included in the study.…”

Section: Discussionmentioning

confidence: 99%

“…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.…”

Section: Introductionmentioning

confidence: 99%

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

Bakker

Kerstjens-Frederikse

Buys

et al. 2009

Birth Defects Research

102

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We exposed normal human epidermal keratinocytes to short duration, high frequency, and low amplitude electromagnetic fields, similar to that used by mobile phone technologies. We paid particular attention to the control of the characteristics of the electromagnetic environment generated within a mode stirred reverberation chamber (statistical homogeneity and isotropy of the field and SAR distribution). Two non‐thermal exposure conditions were tested on the epidermal cells: 10‐min exposure with a field amplitude of 8 V/m, and 30 min with 41 V/m. Corresponding specific absorption rates ranged from 2.6 to 73 mW/kg (continuous wave, 900 MHz carrier frequency). We collected RNA from cells subjected to these conditions and used it for a large‐scale microarray screening of over 47000 human genes. Under these conditions, exposure of keratinocytes to the electromagnetic field had little effect; only 20 genes displayed significant modulation. The expression ratios were very small (close to 1.5‐fold change), and none of them were shared by the two tested conditions. Furthermore, those assayed using polymerase chain reaction did not display significant expression modulation (overall mean of the exposed samples: 1.20 ± 0.18). In conclusion, the data presented here show that cultured keratinocytes are not significantly affected by EMF exposure. Bioelectromagnetics 32:302–311, 2011. © 2010 Wiley‐Liss, Inc.

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Paroxetine in the first trimester and the prevalence of congenital malformations

Cited by 146 publications

References 12 publications

Antidepressant Use in Pregnancy and the Risk for Cardiac Defects

Antidepressant Use in Pregnancy and the Risk for Cardiac Defects

Congenital Heart Disease Associated With Selective Serotonin Reuptake Inhibitor Use During Pregnancy

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

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