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No association between SSRI use in pregnancy and risk of stillbirth or infant mortality

Clinical Question:
Does the use of selective serotonin reuptake inhibitors during pregnancy increase the risk of stillbirth and infant mortality?

Bottom Line:
After controlling for confounding variables, including history of maternal psychiatric disease hospitalizations, no significant association was found between the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy and the risk of stillbirth and infant mortality. (LOE = 1b)

Reference:
Stephansson O, Kieler H, Haglund B, et al. Selective serotonin reuptake inhibitors during pregnancy and risk of stillbirth and infant mortality. JAMA 2013;309(1):48-54.  [PMID:23280224]

Study Design:
Cohort (prospective)

Funding:
Industry + govt

Setting:
Population-based

Synopsis:
The use of SSRIs during pregnancy has been associated with an increased risk of congenital anomalies, spontaneous abortion, and neonatal withdrawal syndrome. Whether SSRIs also increase the risk of stillbirth and infant mortality is uncertain. These investigators analyzed data from a large registry-based cohort study including all women and their infants born in 5 Nordic countries between 1996 and 2007. Only singleton births were included in the final analysis. Information on drug exposure, defined as at least 1 filled prescription for an SSRI from 3 months before pregnancy through date of birth, was obtained from national drug registries. SSRIs used included fluoxetine, citalopram, paroxetine, sertraline, fluvoxamine, and escitalopram. Multiple analyses controlled for possible confounders, including maternal age, parity, birth year, country of birth, maternal disease, history of psychiatric hospitalization, and smoking status. During the study period, 29,228 births (1.79% of total) occurred to mothers who filled a prescription for an SSRI during pregnancy. After adjusting for potential confounders, SSRI exposure was not significantly associated with an increased risk of stillbirth or infant mortality. A separate analysis based on trimester of exposure found an increased risk of stillbirth only among women exposed from 3 months before pregnancy and during the first trimester, but not among those with exposure continuing into the second trimester or entire pregnancy. This result may be spurious and due only to chance. In addition, since there were only 31 stillbirths among women exposed in the first trimester, early exposure may be confounded by association with congenital anomalies. Trimester of exposure was not significantly associated with infant mortality.

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