TABLE 3.
Associations between any atypical antipsychotic medication use from one month before conception through the third month of pregnancy and specific selected birth defects,a National Birth Defects Prevention Study (NBDPS), 1997–2011
| Defect | Atypical Antipsychotic Medication Exposedb,c N | Atypical Antipsychotic Medication Unexposedb,d N | cOR (95% CI)e |
|---|---|---|---|
| Controls | 12 | 11,458 | |
| Any heart defect | 18 | 11,803 | 1.5 (0.7, 3.0) |
| Conotruncal defects | 6 | 2,495 | 2.3 (0.9, 6.1) |
| Tetralogy of Fallot | 3 | 1,154 | 2.5 (0.7, 8.8) |
| LVOTO | 4 | 2,169 | 1.8 (0.6, 5.5) |
| RVOTO | 3 | 2,037 | 1.4 (0.4, 5.0) |
| Septal defects | 4 | 4,529 | 0.8 (0.3, 2.6) |
| Atrial septal defect (secundum or NOS) | 4 | 2,914 | 1.3 (0.4, 4.1) |
| Any orofacial cleftf | 7 | 4,574 | 1.4 (0.6, 3.7) |
| Cleft palatef | 4 | 1,539 | 2.5 (0.8, 7.6) |
| Cleft lip +/− cleft palatef | 3 | 3,035 | 0.9 (0.3, 3.3) |
| Anorectal atresia/stenosis | 3 | 1,028 | 2.8 (0.8, 9.9) |
| Hypospadias, 2/3rd degreef | 3 | 2,510 | 0.8 (0.2, 2.9) |
| Craniosynostosis | 3 | 1,567 | 1.8 (0.5, 6.5) |
| Gastroschisis | 3 | 1,398 | 2.1 (0.6, 7.3) |
This table includes NBDPS birth defects with ≥3 exposed cases. Cases were included in the higher order defect category (e.g., “any heart defect”) even if the more detailed birth defect category was excluded (e.g., hypoplastic left heart syndrome, coarctation of the aorta). The total sample of cases presented in the Method section does not sum to Table 3 individual defects reported as cases may have ≥1 eligible defect;
Atypical antipsychotic medication components with case or control mother exposure included aripiprazole, asenapine, olanzapine, quetiapine, risperidone, and ziprasidone;
Mothers exposed to atypical antipsychotics from the month before conception through the third month of pregnancy;
Mothers unexposed to atypical antipsychotics from three months before conception through the end of pregnancy;
Bolded results in the table reflect elevated associations with cOR ≥2.0;
As any orofacial clefts, cleft palate, and cleft lip +/− cleft palate were only ascertained by a subset of the study sites in certain years, and hypospadias only affects male infants, controls for these analyses were similarly restricted. For orofacial clefts, cleft palate, and cleft lip +/− cleft palate, there were 11 324 unexposed controls and 12 controls who were exposed to atypical antipsychotic medication in early pregnancy. For hypospadias, there were 5,837 unexposed controls and 9 controls who were exposed to atypical antipsychotic medication in early pregnancy;
Abbreviations: 95% CI, 95% confidence interval; cOR, crude (unadjusted) odds ratio; LVOTO, left ventricular outflow tract obstruction; RVOTO, right ventricular outflow tract obstruction; NOS, not otherwise specified.