First trimester paroxetine use and the prevalence of congenital, specifically cardiac, defects: A meta‐analysis of epidemiological studies

Wurst, Keele; Poole, Charles; Ephross, Sara A.; Olshan, Andrew F.

doi:10.1002/bdra.20627

Cited by 137 publications

(108 citation statements)

References 38 publications

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“…Note, however, that this was not a consistent finding, as our main analysis, which was with the higher quality studies, was not significant, although it was reduced to 4 studies. Several meta-analyses previously did report an increased risk for cardiovascular malformations with paroxetine (ie, Bar-Oz et al, 13 Wurst et al 16 ) but, unlike Wurst et al, 16 we did not find an increased risk for congenital malformations with this drug. Ours is the first meta-analysis, to our knowledge, to specifically examine the type of malformation implicated, and our results suggest that septal heart defects are associated with antidepressant exposure.…”

Section: Discussioncontrasting

confidence: 75%

“…Several have found no evidence of increased risk of major congenital malformations above the baseline [8][9][10] rate, which has been widely cited as 1%-3% for any pregnancy in North America [11][12][13][14] and less than 4% for minor congenital malformations. 15 The most recent meta-analyses did report an increased risk for congenital malformations 16 and cardiac malformations 13,16 with paroxetine exposure specifically. Unfortunately, many individual studies have serious methodological limitations 17 that were not taken into account in the previous meta-analyses.…”

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confidence: 99%

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Antidepressant Exposure During Pregnancy and Congenital Malformations: Is There an Association?

Grigoriadis¹,

VonderPorten²,

Mamisashvili³

et al. 2013

J. Clin. Psychiatry

150

117

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Objective: Depression is often not optimally treated during pregnancy, partially because of conflicting data regarding antidepressant medication risk. This meta-analysis was conducted to determine whether antenatal antidepressant exposure is associated with congenital malformations and to assess the effect of known methodological limitations. Data Sources: EMBASE, CINAHL, PsycINFO, and MEDLINE were searched from their start dates to June 2010. Keywords of various combinations were used, including, but not limited to depressive/mood disorder, pregnancy, antidepressant drug/agent, congenital malformation, and cardiac malformation. Study Selection: English language studies reporting congenital malformations associated with antidepressants were included. Of 3,074 abstracts reviewed, 735 studies were retrieved and 27 studies were included. Data Extraction: Two reviewers working independently assessed article quality. Data on use of any antidepressant, including fluoxetine and paroxetine specifically, were extracted. Outcomes included congenital malformations, major congenital malformations, cardiovascular defects, septal heart defects (ventral septal defects and atrial septal defects), and ventral septal defects only. Results: Nineteen studies were above quality threshold and make up the primary meta-analyses. Pooled relative risks (RRs) were derived by using random-effects methods. Antidepressant exposure was not associated with congenital malformations (RR = 0.93; 95% CI, 0.85-1.02; P = .113) or major malformations (RR = 1.07; 95% CI, 0.99-1.17; P = .095). However, increased risk for cardiovascular malformations (RR = 1.36; 95% CI, 1.08-1.71; P = .008) and septal heart defects (RR = 1.40; 95% CI, 1.10-1.77; P = .005) were found; the RR for ventral septal defects was similar to septal defects, although not significant (RR = 1.54; 95% CI, 0.71-3.33; P = .274). Pooled effects were significant for paroxetine and cardiovascular malformations (RR = 1.43; 95% CI, 1.08-1.88; P = .012). These results are contrasted with those addressing methodological limitations but are typically consistent. Conclusions: Overall, antidepressants do not appear to be associated with an increased risk of congenital malformations, but statistical significance was found for cardiovascular malformations. Results were robust in several sensitivity analyses. Given that the RRs are marginal, they may be the result of uncontrolled confounders. Although the RRs were statistically significant, none reached clinically significant levels.

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Section: Discussioncontrasting

confidence: 75%

mentioning

confidence: 99%

Antidepressant Exposure During Pregnancy and Congenital Malformations: Is There an Association?

Grigoriadis¹,

VonderPorten²,

Mamisashvili³

et al. 2013

J. Clin. Psychiatry

150

117

View full text Add to dashboard Cite

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“…13,19 A meta-analysis estimated a 50% increased prevalence of cardiac defects overall with first trimester paroxetine use. 21 It has remained unclear, however, whether these associations are causal, or due to systematic error or chance.…”

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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“…Results from a recent metaanalysis including 20 publications indicate an increased prevalence of combined heart defects associated with first-trimester paroxetine use (Wurst et al, 2009). They also found that variability among individual study findings might be associated with data source, type of publication, and age at ascertainment.…”

Section: Discussionmentioning

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

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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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First trimester paroxetine use and the prevalence of congenital, specifically cardiac, defects: A meta‐analysis of epidemiological studies

Cited by 137 publications

References 38 publications

Antidepressant Exposure During Pregnancy and Congenital Malformations: Is There an Association?

Antidepressant Exposure During Pregnancy and Congenital Malformations: Is There an Association?

Antidepressant Use in Pregnancy and the Risk for Cardiac Defects

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

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