TY - JOUR
T1 - Selective serotonin reuptake inhibitor antidepressant use in first trimester pregnancy and risk of specific congenital anomalies: A European register-based study
AU - Wemakor, Anthony
AU - Casson, Karen
AU - Garne, Ester
AU - Bakker, Marian
AU - Addor, Marie-Claude
AU - Arriola, Larraitz
AU - Gatt, Miriam
AU - Khoshnood, Babak
AU - Klungsoyr, Kari
AU - Nelen, Vera
AU - O'Mahony, Mary
AU - Pierini, Anna
AU - Rissmann, Anke
AU - Tucker, David
AU - Boyle, Breidge
AU - de Jong-van den Berg, Lolkje
AU - Dolk, Helen
PY - 2015/11/30
Y1 - 2015/11/30
N2 - Abstract Evidence of an association between early pregnancy exposure to selective serotonin reuptake inhibitors (SSRI) and congenital heart defects (CHD) has contributed to recommendations to weigh benefits and risks carefully. The objective of this study was to determine the specificity of association between first trimester exposure to SSRIs and specific CHD and other congenital anomalies (CA) associated with SSRI exposure in the literature (signals). A population-based case-malformed control study was conducted in 12 EUROCAT CA registries covering 2.1 million births 1995–2009 including livebirths, fetaldeaths from 20 weeks gestation and terminations of pregnancy for fetal anomaly. Babies/fetuses with specific CHD (n = 12,876) and non-CHD signal CA (n = 13,024), were compared with malformed controls whose diagnosed CA have not been associated with SSRI in the literature (n = 17,083). SSRI exposure in first trimester pregnancy was associated with CHD overall (OR adjusted for registry 1.41, 95 % CI 1.07–1.86, fluoxetine adjOR 1.43 95 % CI 0.85–2.40, paroxetine adjOR 1.53, 95 % CI 0.91–2.58) andwith severe CHD (adjOR 1.56, 95 % CI 1.02–2.39), particularly Tetralogy of Fallot (adjOR 3.16, 95 % CI1.52–6.58) and Ebstein’s anomaly (adjOR 8.23, 95 % CI 2.92–23.16). Significant associations with SSRI exposure were also found for ano-rectal atresia/stenosis (adjOR 2.46, 95 % CI 1.06–5.68), gastroschisis (adjOR 2.42, 95 % CI 1.10–5.29), renal dysplasia (adjOR 3.01, 95 % CI1.61–5.61), and clubfoot (adjOR 2.41, 95 % CI 1.59–3.65). These data support a teratogenic effect of SSRIs specific to certain anomalies, but cannot exclude confounding byindication or associated factors.
AB - Abstract Evidence of an association between early pregnancy exposure to selective serotonin reuptake inhibitors (SSRI) and congenital heart defects (CHD) has contributed to recommendations to weigh benefits and risks carefully. The objective of this study was to determine the specificity of association between first trimester exposure to SSRIs and specific CHD and other congenital anomalies (CA) associated with SSRI exposure in the literature (signals). A population-based case-malformed control study was conducted in 12 EUROCAT CA registries covering 2.1 million births 1995–2009 including livebirths, fetaldeaths from 20 weeks gestation and terminations of pregnancy for fetal anomaly. Babies/fetuses with specific CHD (n = 12,876) and non-CHD signal CA (n = 13,024), were compared with malformed controls whose diagnosed CA have not been associated with SSRI in the literature (n = 17,083). SSRI exposure in first trimester pregnancy was associated with CHD overall (OR adjusted for registry 1.41, 95 % CI 1.07–1.86, fluoxetine adjOR 1.43 95 % CI 0.85–2.40, paroxetine adjOR 1.53, 95 % CI 0.91–2.58) andwith severe CHD (adjOR 1.56, 95 % CI 1.02–2.39), particularly Tetralogy of Fallot (adjOR 3.16, 95 % CI1.52–6.58) and Ebstein’s anomaly (adjOR 8.23, 95 % CI 2.92–23.16). Significant associations with SSRI exposure were also found for ano-rectal atresia/stenosis (adjOR 2.46, 95 % CI 1.06–5.68), gastroschisis (adjOR 2.42, 95 % CI 1.10–5.29), renal dysplasia (adjOR 3.01, 95 % CI1.61–5.61), and clubfoot (adjOR 2.41, 95 % CI 1.59–3.65). These data support a teratogenic effect of SSRIs specific to certain anomalies, but cannot exclude confounding byindication or associated factors.
KW - Congenital anomaly
KW - SSRI
KW - Depression
KW - Epidemiology
KW - Registry
KW - Medication
UR - https://pure.ulster.ac.uk/en/publications/selective-serotonin-reuptake-inhibitor-antidepressant-use-in-firs-3
U2 - 10.1007/s10654-015-0065-y
DO - 10.1007/s10654-015-0065-y
M3 - Article
SN - 0393-2990
VL - 30
SP - 1187
EP - 1198
JO - European Journal of Epidemiology
JF - European Journal of Epidemiology
IS - 11
ER -