Pregnancy Outcome Following Maternal Use of the New Selective Serotonin Reuptake Inhibitors

Abstract

Context.-Although a large number of women of reproductive age use new selective serotonin reuptake inhibitors (SSRIs) and half of all pregnancies are unplanned, no data exist on the safety of these agents for the human fetus. Objective.-To assess fetal safety and risk of fluvoxamine, paroxetine, and sertraline. Design.-A prospective, multicenter, controlled cohort study. Setting.-Nine Teratology Information Service centers in the United States and Canada. Patients.-All women who were counseled during pregnancy following exposure to a new SSRI and followed up by the participating centers. Controls were randomly selected from women counseled after exposure to nonteratogenic agents. Main Outcome Measures.-Rates of major congenital malformations. Results.-A total of 267 women exposed to an SSRI and 267 controls were studied. Exposure to SSRIs was not associated with either increased risk for major malformations (9/222 live births [4.1%] vs 9/235 live births [3.8%] in the controls, relative risk, 1.06, 95% confidence interval, 0.43-2.62) or higher rates of miscarriage, stillbirth, or prematurity. Mean (SD) birth weights among SSRI users (3439 [505] g) were similar to the controls (3445 [610] g) as were the gestational ages (39.4 [1.7] weeks vs 39.4 [1.9] weeks). Conclusion.-The new SSRIs, fluvoxamine, paroxetine, and sertraline, do not appear to increase the teratogenic risk when used in their recommended doses.

Reintroduction of Antidepressant Therapy across Pregnancy in Women Who Previously Discontinued Treatment

“…In the current study, patients with a wide spectrum of illness severity, including those with highly recurrent illness, elected to discontinue antidepressants during pregnancy frequently to avoid fetal exposure to these medications. That patients with even highly recurrent illness elected to discontinue antidepressant therapy is not surprising given concerns about prenatal exposure to medications, particularly when only sparse data regarding risks of fetal exposure are available for some of the most widely used antidepressants [5, 8]. Nonetheless, nearly half the sample (42%) reintroduced treatment with these agents, including those with and without multiple recurrences.…”

Short-Term Neonatal Outcome among Term Infants after in utero Exposure to Serotonin Reuptake Inhibitors

“…These medications are considered to be safe during pregnancy due to their large therapeutic range and fewer adverse effects in comparison to other antidepressant medications [1,2,3]. …”

Treatment of nonpsychotic major depression during pregnancy: patient safety and challenges

“…However, not all studies are in agreement,89,90,92,100,166,167 and one study even documented a reduced risk of spontaneous preterm birth associated with medication treatment of depressive symptoms during pregnancy, although the main exposure group included both sedative medications and antidepressants 32. Most studies to date have focused on antenatal SSRI use; however, an increased risk of preterm delivery has also been reported for TCAs, venlafaxine, and mirtazapine 97,127,128…”

“…The majority of individual studies have not demonstrated increased risk of MCMs associated with antidepressant exposure in the first trimester or at any time during pregnancy 87,89,92–104. Meta-analyses of studies investigating the risk of antidepressants and “any” or “overall” MCMs have shown either small but statistically significant risk105,106 or absence of significant increase in risk (Table 2).…”