Table 3.
Major congenital anomalies in infants exposed to varenicline in the first trimester and matched comparison group. Data presented are numbers (percentage) of outcomes and hazard ratios (95% confidence interval)
| Varenicline, 1st trimester | Unexposed | Hazard ratio (95% CI)† | |
|---|---|---|---|
| Any major congenital anomaly | 20 (2.9%) | 242 (3.5%) | 0.91 (0.72–1.15) |
| Genitourinary | 7 (1.0%) | 67 (1.0%) | 1.00 (0.67–1.51) |
| Cardiovascular | 6 (0.9%) | 52 (0.7%) | 1.16 (0.75–1.79) |
| Musculoskeletal | < 5 | 57 (0.8%) | – |
| Gastrointestinal | < 5 | 28 (0.4%) | – |
| Nevers | < 5 | 18 (0.3%) | – |
| Respiratory | < 5 | 6 (0.1%) | – |
| Eyes | < 5 | 11 (0.2%) | – |
| Face, neck | 0 | < 5 | – |
| Integumentary | 0 | < 5 | – |
| Genetic syndromes | < 5 | 7 (0.1%) | – |
| Situs inversus | 0 | < 5 | – |
| Others | < 5 | 9 (0.1%) | – |
†Hazard ratio was obtained from the univariate model