There is no other example in human teratology where, after more than 40 epidemiological studies, repeated meta-analyses and thousands of pregnancies, the fetal safety or risk of an agent has not been verified and settled.
The objectives of the present review were to identify and discuss sources of bias that may lead clinicians and scientists to believe that SRIs cause malformation or other adverse outcomes, where, in fact, they may not.
The present study highlights sources of bias that may explain why children exposed in utero to SRI exhibit higher rates of congenital malformations, mostly cardiovascular and other complications. It appears that pregnant women treated for depression and anxiety are distinctively different from healthy women in numerous covariates, which may confound pregnancy outcomes. Acknowledging and adjusting for these sources of bias are critical before one selects to withhold therapy for moderate or severe cases of depression and anxiety in pregnancy.