Seven studies (n=17,526) were eligible for inclusion.
The quality of the included studies ranged from 60 to 93%, with 5 studies scoring at least 80%.
Significantly more children were born with major malformations (OR 1.31, 95% CI: 1.03, 1.67; 7 studies) and cardiac only malformations (OR 1.72, 95% CI: 1.22, 2.42; 6 studies) to women who were exposed to paroxetine during the first trimester than to women exposed to other antidepressants or non-teratogenic medications in the first trimester. There was no significant difference in the occurrence of major malformations when cardiac malformations were excluded (OR 1.29, 95% CI: 0.86, 1.92).
A subgroup analysis restricted to studies in which the control group consisted of women taking other antidepressants (4 studies) showed that the rate of cardiac malformations remained higher in women taking paroxetine (OR 1.70, 95% CI: 1.17, 2.46). There was no significant difference in major malformations between the groups (OR 1.30, 95% CI: 0.93, 1.8). There was no significant difference in the rates of cardiac malformation or major malformation when comparing children born to women exposed to paroxetine and those born to women taking known non-teratogenic medications (3 studies).