Evaluation of the risk of congenital cardiovascular defects associated with use of paroxetine during pregnancy.

OBJECTIVE: In 2005-2006, several studies noted an increased risk of cardiovascular birth defects associated with maternal use of paroxetine compared with other antidepressants in the same class. In this study, the authors sought to determine whether paroxetine was associated with an increased risk of cardiovascular defects in infants of women exposed to the drug during the first trimester of pregnancy. METHOD: From teratology information services around the world, the authors collected prospectively ascertained, unpublished cases of infants exposed to paroxetine early in the first trimester of pregnancy and compared them with an unexposed cohort. The authors also contacted the authors of published database studies on antidepressants as a class to determine how many of the women in those studies had been exposed to paroxetine and the rates of cardiovascular defects in their infants. RESULTS: The authors were able to ascertain the outcomes of 1,174 infants from eight services. The rates of cardiac defects in the paroxetine group and in the unexposed group were both 0.7%. The rate in the database studies (2,061 cases from four studies) was 1.5%. CONCLUSIONS: Paroxetine does not appear to be associated with an increased risk of cardiovascular defects following use in early pregnancy, as the incidence in more than 3,000 infants was well within the population incidence of approximately 1%

Paternal Organic Solvent Exposure and Adverse Pregnancy Outcomes: A Meta-Analysis

Background: Organic solvents are widely used, but conflicting reports exist concerning paternal exposure and adverse pregnancy outcomes. We conducted a meta-analysis to assess the risks of spontaneous abortions (SAs) and major malformations (MMs) after paternal exposure to organic solvents. Methods: Medline, Toxline, Reprotox, and Embase from 1966 to 2003 were searched. Two independent reviewers searched for cohort and case-control studies in any language on adult human males exposed chronically to any organic solvent. Two non-blinded independent extractors used a standardized form for data extraction; disagreements were resolved through consensus discussion. Results: Forty-seven studies were identified; 32 exclusions left 14 useable studies. Overall random effects odds ratios and 95% confidence intervals (CI95%) were 1.30 (CI95%: 0.81– 2.11, N=1,248) for SA, 1.47 (CI95%: 1.18–1.83, N=384,762) for MMs, 1.86 (CI95%: 1.40–2.46,N=180,242) for any neural tube defect, 2.18 (CI95%: 1.52–3.11,N=107,761) for anencephaly, and 1.59 (CI95%: 0.99–2.56, N=96,517; power=56.3%) for spina bifida. Conclusions: Paternal exposure to organic solvents is associated with an increased risk for neural tube defects but not SAs