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)

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%)

–