Research Article

[Retracted] Fetal Congenital Cardiac and Vascular Disorders Associated with Sertraline Treatment during Pregnancy: Analysis of FAERS Data

Table 3

Signal detection for sertraline-associated congenital cardiovascular disease in the FAERS database.

Reaction (PT code)CaseROR (95% two-sided CI)PRR (95% two-sided CI, )BCPNN (IC-2SD)EBGM (90% two-sided CI)

Heart disease congenital (10019273)12822.6 (18.88, 27.06)22.56 (22.38, 22.74, 2429.61)4.19 (4.12)21.02 (20.87, 21.17)
Atrial septal defect (10003664)12715.63 (13.07, 18.69)15.6 (15.42, 15.78, 1634.23)3.74 (3.69)14.86 (14.71, 15.01)
Ventricular septal defect (10047298)9916.12 (13.17, 19.74)16.1 (15.90, 16.30, 1315.07)3.74 (3.68)15.32 (15.15, 15.49)
Patent ductus arteriosus (10034130)7219.15 (15.09, 24.31)19.13 (18.89, 19.37, 1144.72)3.87 (3.78)18.02 (17.82, 18.22)
Persistent fetal circulation (10034708)3437.82 (26.46, 54.06)37.8 (37.45, 38.16, 1047.24)4.12 (3.95)33.62 (33.32, 33.92)
Fallot’s tetralogy (10016193)3020.42 (14.11, 29.57)20.41 (20.04, 20.78, 499.97)3.59 (3.46)19.16 (18.85, 19.47)
Transposition of the great vessels (10044443)2724.12 (16.29, 35.71)24.11 (23.72, 24.50, 531.58)3.66 (3.51)22.36 (22.03, 22.69)
Pulmonary valve stenosis congenital (10037451)2135.17 (22.37, 55.30)35.16 (34.70, 35.61, 592.37)3.72 (3.51)31.52 (31.14, 31.89)
Cardiac septal defect (10064021)2129.2 (18.65, 45.72)29.19 (28.74, 29.64, 494.71)3.62 (3.43)26.65 (26.27, 27.02)
Pulmonary artery stenosis congenital (10037339)2021.05 (13.37, 33.14)21.05 (20.59, 21.50, 337.90)3.38 (3.21)19.71 (19.33, 20.09)
Coarctation of the aorta (10009807)1914.11 (8.90, 22.35)14.1 (13.64, 14.56, 208.35)3.05 (2.91)13.5 (13.12, 13.89)
Hypoplastic left heart syndrome (10021076)1819.58 (12.15, 31.55)19.57 (19.09, 20.05, 280.22)3.26 (3.09)18.41 (18.01, 18.81)
Bicuspid aortic valve (10004552)1722.27 (13.60, 36.46)22.26 (21.77, 22.76, 301.45)3.3 (3.12)20.77 (20.36, 21.18)
Newborn persistent pulmonary hypertension (10053592)15176.83 (93.23, 335.42)176.79 (176.15, 177.43, 1530.31)3.81 (3.36)110.87 (110.33, 111.40)
Haemangioma congenital (10018818)1440.85 (23.36, 71.45)40.84 (40.28, 41.40, 443.43)3.43 (3.16)35.99 (35.52, 36.46)
Congenital cardiovascular anomaly (10061054)148.72 (5.13, 14.84)8.72 (8.19, 9.25, 85.58)2.5 (2.37)8.5 (8.05, 8.94)
Congenital heart valve disorder (10064086)1235.36 (19.43, 64.36)35.36 (34.76, 35.96, 327.59)3.23 (2.96)31.68 (31.18, 32.18)
Congenital aortic valve stenosis (10010371)957.66 (28.22, 117.80)57.65 (56.93, 58.36, 372.82)3.07 (2.69)48.38 (47.78, 48.98)
Hypertrophic cardiomyopathy (10020871)97.78 (4.01, 15.08)7.78 (7.11, 8.44, 45.37)2.19 (2.04)7.6 (7.05, 8.16)
Congenital coronary artery malformation (10061060)858.94 (27.59, 125.92)58.93 (58.17, 59.69, 332.75)2.95 (2.54)49.27 (48.64, 49.91)
Trisomy 21 (10044688)85.12 (2.55, 10.31)5.12 (4.43, 5.82, 22.19)1.8 (1.67)5.05 (4.47, 5.64)
Pulmonary artery atresia (10037337)847.15 (22.35, 99.46)47.14 (46.40, 47.89, 272.85)2.91 (2.53)40.78 (40.15, 41.40)
Double outlet right ventricle (10013611)718.42 (8.58, 39.53)18.42 (17.65, 19.18, 92.68)2.51 (2.24)17.39 (16.75, 18.03)
Shone complex (10066802)6104 (41.00, 263.80)103.99 (103.06, 104.92, 379.20)2.69 (2.11)77.13 (76.35, 77.90)
Aorta hypoplasia (10049209)516.01 (6.51, 39.39)16.01 (15.11, 16.91, 53.23)2.17 (1.88)15.24 (14.49, 15.99)
Congenital mitral valve stenosis (10010548)573.67 (27.65, 196.29)73.66 (72.68, 74.64, 231.34)2.46 (1.90)59.13 (58.31, 59.95)
Multiple cardiac defects (10028178)522.32 (8.99, 55.41)22.32 (21.41, 23.23, 75.82)2.27 (1.93)20.82 (20.06, 21.58)
Anomalous pulmonary venous connection (10058079)412.41 (4.56, 33.74)12.41 (11.41, 13.41, 30.02)1.9 (1.61)11.95 (11.11, 12.78)
Atrioventricular septal defect (10063836)47.96 (2.95, 21.50)7.96 (6.97, 8.96, 17.40)1.72 (1.49)7.78 (6.95, 8.61)
Congenital aortic stenosis (10010369)413.87 (5.09, 37.80)13.87 (12.86, 14.87, 34.11)1.94 (1.63)13.29 (12.45, 14.13)
Corrected transposition of great vessels (10011120)4589.33 (107.94, 3217.69)589.29 (587.60, 590.99, 598.66)2.29 (1.20)197.1 (195.68, 198.52)
Ventricular hypoplasia (10047296)310.16 (3.21, 32.12)10.16 (9.01, 11.31, 15.89)1.61 (1.31)9.85 (8.89, 10.82)
Univentricular heart (10045545)318.81 (5.85, 60.43)18.81 (17.64, 19.97, 32.23)1.77 (1.37)17.74 (16.76, 18.72)
Truncus arteriosus persistent (10044703)323.89 (7.37, 77.49)23.89 (22.71, 25.07, 41.47)1.81 (1.36)22.17 (21.19, 23.16)
Congenital pulmonary artery anomaly (10061074)319.22 (5.98, 61.79)19.22 (18.05, 20.38, 32.99)1.77 (1.37)18.1 (17.12, 19.08)
Congenital tricuspid valve stenosis (10010656)373.67 (20.79, 261.06)73.66 (72.40, 74.93, 118.64)1.92 (1.20)59.13 (58.07, 60.19)
Congenital pulmonary valve atresia (10052644)38.26 (2.62, 26.02)8.26 (7.11, 9.41, 12.21)1.54 (1.27)8.06 (7.10, 9.02)
Dextrocardia (10012592)315.24 (4.78, 48.64)15.24 (14.08, 16.40, 25.58)1.73 (1.36)14.54 (13.57, 15.51)
Congenital pulmonary valve disorder (10061075)215.93 (3.84, 66.09)15.93 (14.50, 17.35, 14.24)1.4 (0.95)15.16 (13.97, 16.35)
Trisomy 18 (10053884)25.12 (1.27, 20.74)5.12 (3.73, 6.52, 3.09)1.1 (0.83)5.05 (3.88, 6.22)
Hypoplastic right heart syndrome (10064962)28.93 (2.19, 36.46)8.93 (7.52, 10.34, 7.04)1.28 (0.93)8.7 (7.52, 9.87)
Noonan syndrome (10029748)239.29 (8.98, 171.81)39.29 (37.81, 40.76, 36.31)1.5 (0.82)34.78 (33.55, 36.02)
Congenital arterial malformation (10062325)211.56 (2.81, 47.47)11.55 (10.14, 12.97, 9.76)1.34 (0.95)11.16 (9.97, 12.34)
Vascular malformation (10074979)28.54 (2.09, 34.84)8.54 (7.13, 9.95, 6.63)1.27 (0.93)8.33 (7.15, 9.50)
Right ventricle outflow tract obstruction (10064195)214.03 (3.40, 57.97)14.03 (12.61, 15.45, 12.31)1.38 (0.95)13.44 (12.25, 14.63)
Congenital aortic anomaly (10061052)28.67 (2.12, 35.36)8.67 (7.26, 10.07, 6.76)1.27 (0.93)8.45 (7.27, 9.62)
Congenital mitral valve incompetence (10010547)213.7 (3.32, 56.58)13.7 (12.29, 15.12, 11.98)1.38 (0.95)13.14 (11.95, 14.33)
Interruption of aortic arch (10022599)222.67 (5.38, 95.50)22.67 (21.23, 24.10, 20.92)1.45 (0.91)21.12 (19.91, 22.32)
Cor triatriatum (10010972)149.11 (5.91, 407.93)49.11 (46.99, 51.22, 9.62)0.96 (-0.06)42.24 (40.46, 44.01)
Digeorge’s syndrome (10012979)17.96 (1.09, 58.04)7.96 (5.98, 9.95, 1.08)0.82 (0.36)7.78 (6.12, 9.44)
Heart block congenital (10019263)110.91 (1.48, 80.31)10.91 (8.92, 12.91, 1.74)0.87 (0.33)10.56 (8.89, 12.23)
Trisomy 13 (10044686)15.56 (0.77, 40.20)5.56 (3.58, 7.54, 0.55)0.75 (0.36)5.48 (3.82, 7.13)
Congenital aortic dilatation (10058150)132.74 (4.15, 258.43)32.74 (30.67, 34.80, 6.45)0.95 (0.08)29.56 (27.84, 31.29)
Persistent left superior vena cava (10064193)18.42 (1.15, 61.45)8.42 (6.43, 10.41, 1.18)0.83 (0.36)8.21 (6.55, 9.88)
Aorticopulmonary septal defect (10063732)132.74 (4.15, 258.43)32.74 (30.67, 34.80, 6.45)0.95 (0.08)29.56 (27.84, 31.29)
Malformation venous (10025532)110.16 (1.38, 74.59)10.16 (8.17, 12.15, 1.57)0.86 (0.34)9.85 (8.19, 11.52)
Ebstein’s anomaly (10014075)15.17 (0.72, 37.33)5.17 (3.19, 7.15, 0.47)0.74 (0.36)5.1 (3.44, 6.75)
Fallot’s pentalogy (10059205)1147.33 (13.36, 1624.84)147.32 (144.92, 149.72, 23.73)0.98 (-0.46)98.55 (96.54, 100.56)
Ductus arteriosus stenosis fetal (10013808)11.94 (0.27, 13.85)1.94 (-0.03, 3.90, 0.00)0.4 (0.16)1.93 (0.29, 3.58)
Ductus arteriosus premature closure (10049996)11.89 (0.26, 13.49)1.89 (-0.08, 3.86, 0.00)0.38 (0.15)1.88 (0.24, 3.53)
Vacterl syndrome (10066022)15.36 (0.74, 38.71)5.36 (3.38, 7.33, 0.51)0.75 (0.36)5.28 (3.62, 6.93)
Congenital aortic atresia (10010368)124.55 (3.19, 188.85)24.55 (22.51, 26.59, 4.75)0.93 (0.16)22.74 (21.04, 24.45)
Ectopia cordis (10014144)158.93 (6.88, 504.44)58.93 (56.78, 61.08, 11.38)0.97 (-0.12)49.27 (47.48, 51.07)
Cardiac malposition (10007585)136.83 (4.61, 294.50)36.83 (34.75, 38.91, 7.27)0.95 (0.04)32.85 (31.11, 34.59)
Mitral valve atresia (10066800)115.51 (2.08, 115.85)15.51 (13.50, 17.52, 2.77)0.9 (0.27)14.78 (13.10, 16.47)
Congenital tricuspid valve atresia (10049767)15.17 (0.72, 37.33)5.17 (3.19, 7.15, 0.47)0.74 (0.36)5.1 (3.44, 6.75)
Charge syndrome (10064063)132.74 (4.15, 258.43)32.74 (30.67, 34.80, 6.45)0.95 (0.08)29.56 (27.84, 31.29)
Right aortic arch (10067407)14.68 (0.65, 33.72)4.68 (2.70, 6.65, 0.37)0.71 (0.36)4.62 (2.97, 6.27)
Congenital aortic valve incompetence (10010370)14.53 (0.63, 32.67)4.53 (2.56, 6.51, 0.34)0.71 (0.35)4.48 (2.83, 6.13)