Risk of major cardiac malformations associated with paroxetine use during the first trimester of pregnancy

The risk of major cardiac malformations associated with paroxetine use during the first trimester of pregnancy: A systematic review and meta-analysis

 

http://onlinelibrary.wiley.com/doi/10.1111/bcp.12849/abstract

  1. Anick Bérard1,2,*,
  2. Noha Iessa1,2,
  3. Sonia Chaabane1,2,
  4. Flory T. Muanda1,2,
  5. Takoua Boukhris1,2 and
  6. Jin-Ping Zhao1,2

DOI: 10.1111/bcp.12849

Article has an altmetric score of 190

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Author InformationPublication History

  1. This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/bcp.12849.

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Keywords:

  • Paroxetine;
  • pregnancy;
  • major malformations;
  • cardiac malformations;
  • meta-analysis

Aims

The aim of this study was to perform an up-to-date meta-analysis on the risk of cardiac malformations associated with gestational exposure to paroxetine, taking into account indication, study design, and reference category.

Method

A systematic review of studies published between 1966 and November 2015 was conducted using EMBASE and MEDLINE. Studies reporting major malformations with first trimester exposure to paroxetine were included. Potentially relevant articles were assessed and relevant data extracted to calculate risk estimates. Outcomes included any major malformations, and major cardiac malformations. Pooled odds ratios and 95% confidence intervals were calculated using random-effects models.

Results

Twenty-three studies were included. Compared to non-exposure to paroxetine, first trimester use of paroxetine was associated with an increased risk of any major congenital malformations combined (pooled OR 1.23, 95% CI 1.10, 1.38; n=15 studies); major cardiac malformations (pooled OR 1.28, 95% CI 1.11, 1.47; n=18 studies), specifically bulbus cordis anomalies and anomalies of cardiac septal closure (pooled OR 1.42, 95% CI 1.07, 1.89; n=8 studies), atrial septal defects (pooled OR 2.38, 95% CI 1.14, 4.97; n=4 studies), and right ventricular outflow track defect (pooled OR 2.29, 95% CI 1.06, 4.93; n=4 studies). Although the estimates varied depending on the comparator group, study design and malformation detection period, a trend towards increased risk was observed.

Conclusions

Paroxetine use during the first trimester of pregnancy is associated with an increased risk of any major congenital malformations and cardiac malformations. The increase in risk is not dependent on the study method or population.

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