Risks of congenital malformations and perinatal events among infants exposed to antidepressant medications during pregnancy
ABSTRACT To evaluate risks for perinatal complications and congenital defects among infants exposed in utero to antidepressants.
We identified 2201 women who were prescribed an antidepressant during pregnancy and who delivered an infant within one of five large managed care organizations (HMO). Prescription drug dispensings and inpatient and outpatient diagnoses were obtained from automated databases at each HMO. Antidepressants were categorized into tricyclic antidepressants (TCAs) or selective serotonin reuptake inhibitors (SSRIs), and medication timing was assessed by trimester. Rates of congenital anomalies or perinatal complications were compared to infants whose mothers were not prescribed antidepressants during pregnancy.
Infants exposed to SSRIs or TCAs during pregnancy had a significant increase in preterm delivery risk. Fullterm infants exposed to SSRIs during the third trimester had an increased risk for respiratory distress syndrome, endocrine and metabolic disturbances, hypoglycemia, temperature regulation disorders, and convulsions. Third-trimester exposure to TCAs was also associated with an increased risk for respiratory distress syndrome, endocrine and metabolic disturbances, and temperature regulation disorders. There were 182 infants exposed to Paroxetine, and these infants did not have an increased risk of cardiac septal defects.
SSRIs and TCAs did not show a consistent link with congenital anomalies. Paroxetine exposure was not linked with an increased risk for cardiovascular anomalies, although our study power to detect a moderate increase in risk was limited. Infants exposed to antidepressants were at increased risk for preterm delivery. Both SSRIs and TCAs used during the third trimester appeared to increase the risk for perinatal complications and their use should be managed carefully among pregnant women with depression.
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ABSTRACT: In pregnant women with major depression, the overarching goal of treatment is to achieve or maintain maternal euthymia, thus limiting both maternal and fetal exposure to the harmful effects of untreated or incompletely treated depression. However, the absence of uniformly effective therapies with guaranteed obstetric and fetal safety makes the treatment of major depression during pregnancy among the most formidable of clinical challenges. Clinicians and patients are still faced with conflicting data and expert opinion regarding the reproductive safety of antidepressants in pregnancy, as well as large gaps in our understanding of the effectiveness of most antidepressants and nonpharmacological alternatives for treating antenatal depression. In this paper, we provide a clinically focused review of the available information on potential maternal and fetal risks of untreated maternal depression during pregnancy, the effectiveness of interventions for maternal depression during pregnancy, and potential obstetric, fetal, and neonatal risks associated with antenatal antidepressant use.Drug, Healthcare and Patient Safety 09/2014; 6:109-29. DOI:10.2147/DHPS.S43308
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ABSTRACT: Background Previous studies suggest a possible association between maternal use of selective serotonin-reuptake inhibitors (SSRIs) during early pregnancy and congenital heart defects (CHD). The purpose of this study was to verify this association by using validated data from the Danish EUROCAT Register, and secondary, to investigate whether the risk differs between various socioeconomic groups. Methods We conducted a cohort study based on Danish administrative register data linked with the Danish EUROCAT Register, which includes all CHD diagnosed in live births, fetal deaths and in pregnancies terminated due to congenital anomalies. The study population consisted of all registered pregnancies (n = 72,280) in Funen, Denmark in the period 1995–2008. SSRI-use was assessed using The Danish National Prescription Registry, information on marital status, maternal educational level, income, and country of origin from Statistics Denmark was used as indicators of socioeconomic situation, and the CHD were studied in subgroups defined by EUROCAT. Logistic Regression was used to investigate the association between redeemed prescriptions for SSRIs and CHD. Results The risk of severe CHD in the offspring of the 845 pregnant women who used SSRIs during first trimester increased four times (AOR 4.03 (95% CI 1.75-9.26)). We found no increased risk of septal defects. Socioeconomic position did not modify the association between maternal SSRI-use during pregnancy and severe CHD. Conclusion This study, which is based on data with high case ascertainment, suggests that maternal use of SSRIs during first trimester increases the risk of severe CHD, but does not support findings from previous studies, based on administrative register data, regarding an increased risk of septal defects. The study was unable to document an interaction between socioeconomic status and maternal SSRI-use on the risk of severe CHD.BMC Pregnancy and Childbirth 09/2014; 14(1):333. DOI:10.1186/1471-2393-14-333 · 2.15 Impact Factor
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ABSTRACT: In recent years, a number of authors have advocated the merits of conducting randomised controlled trials (RCTs) of antidepressants in women with nervous disorders during the prenatal period. However, a critical review of the literature indicates RCTs are not justifiable. At a time when it has become clear that a significant proportion of the existing literature on the use of pharmaceutical agents is ghostwritten, ethicists and others making assertions that RCTs are needed risk becoming part of an apparatus that plays down the hazards of treatment and promotes the use of treatments that may be harmful.