Drugs, pregnancy, and lactation: SSRIs and neonatal neurobehavior.(Obstetrics)

With increasing recognition and treatment of depression in women during their childbearing years, more patients and their physicians are faced with the dilemma of whether to use antidepressants in pregnancy.

The literature over the last decade has been relatively consistent regarding the absence of teratogenic effects associated with the use of selective serotonin re-uptake inhibitors (SSRIs). The data have not been so straightforward regarding the potential risk for perinatal syndromes when these drugs are used during pregnancy.

An increasing number of studies have described syndromes occurring during the perinatal period in babies whose mothers used SSRIs. Symptoms ascribed to perinatal exposure to SSRIs have included tremulousness, increased motor activity, jitteriness, and heightened startle. One trial suggested that fluoxetine (Prozac, Sarafem) exposure during the latter part of pregnancy through labor and delivery was associated with higher rates of special care nursery admissions for what the authors called "poor neonatal adaption." But in another study, my colleagues and I found no evidence of neonatal toxicity in newborns exposed to fluoxetine at term that could be directly ascribed to exposure to this medicine.

Studies that have evaluated the effects of SSRIs on neonatal outcome have suffered from consistent methodologic limitations, the most notable being the failure to blind investigators evaluating the infants with regard to in utero drug exposure and the failure to take into account the potential impact of maternal mood disorder on acute neonatal outcome.

In a study published last month, 34 healthy, full birthweight newborns were evaluated in a prospective trial; 17 mothers took SSRIs during pregnancy and 17 were unexposed. The investigators noted that exposed newborns exhibited significantly more tremors, heightened levels of motor activity and tremulousness, and fewer changes in behavioral state during an hour-long observation period, compared with unexposed newborns (Pediatrics 113[2]:368-75, 2004).

While this is an important study, in which the evaluators were blinded, it is limited by its small sample size. Though both groups were matched for maternal use of cigarettes, alcohol, and marijuana during pregnancy, alcohol use was not insignificant, and four women on SSRIs used marijuana while pregnant.

Most notably, the study failed to include an assessment of maternal mood during pregnancy and did ...