Table 2.
Absolute risks of congenital malformations in infants born to mothers exposed or not exposed to fluconazole during the first trimester in Medicaid Analytic eXtract 2000-14
| Outcome | Pregnancies exposed to fluconazole (n=37 650) | Pregnancies not exposed (n=1 875 257) | Pregnancies exposed to topical or vaginal azoles (n=82 090) | |||||
|---|---|---|---|---|---|---|---|---|
| Events (No of affected pregnancies) |
Risk per 10 000 infants (95% CI) | Events (No of affected pregnancies) |
Risk per 10 000 infants (95% CI) | Events (No of affected pregnancies) |
Risk per 10 000 infants (95% CI) | |||
| Primary outcomes | ||||||||
| Musculoskeletal malformations | 196 | 52.1 (44.8 to 59.3) | 7129 | 38.0 (37.1 to 38.9) | 306 | 37.3 (33.1 to 41.4) | ||
| Conotruncal malformations | 36 | 9.6 (6.4 to 12.7) | 1412 | 7.5 (7.1 to 7.9) | 68 | 8.3 (6.3 to 10.3) | ||
| Oral cleft | 35 | 9.3 (6.2 to 12.4) | 2204 | 11.8 (11.3 to 12.2) | 87 | 10.6 (8.4 to 12.8) | ||
| Secondary outcomes | ||||||||
| Cardiac overall | 396 | 105.2 (94.9 to 115.5) | 16 192 | 86.3 (85.0 to 87.7) | 761 | 92.7 (86.2 to 99.3) | ||
| Malformations overall | 1458 | 387.3 (367.8 to 406.7) | 61 633 | 328.7 (326.1 to 331.2) | 2,840 | 346.0 (333.5 to 358.5) | ||
| Musculoskeletal malformation subgroups | ||||||||
| Deformities of skull, face, and jaw | 72 | 19.1 (14.7 to 23.5) | 2600 | 13.9 (13.3 to 14.4) | 103 | 12.5 (10.1 to 15.0) | ||
| Congenital genu recurvatum and bowing of long bones of leg | <11 | 1.9 (0.5 to 3.2) | 160 | 0.9 (0.7 to 1.0) | <11 | 1.1 (0.4 to 1.8) | ||
| Deformities of feet | 87 | 23.1 (18.3 to 28.0) | 3279 | 17.5 (16.9 to 18.1) | 150 | 18.3 (15.4 to 21.2) | ||
| Deformities of spine | 16 | 4.2 (2.2 to 6.3) | 508 | 2.7 (2.5 to 2.9) | 20 | 2.4 (1.4 to 3.5) | ||
| Dystrophic growth of the bone and dysplasia | <11 | 2.1 (0.7 to 3.6) | 252 | 1.3 (1.2 to 1.5) | 11 | 1.3 (0.6 to 2.1) | ||
| Other anomalies of ribs and sternum | <11 | 0.8 (−0.1 to 1.7) | 65 | 0.3 (0.3 to 0.4) | <11 | 0.6 (0.1 to 1.1) | ||
| Other anomalies of musculoskeletal system | <11 | 2.1 (0.7 to 3.6) | 254 | 1.4 (1.2 to 1.5) | 16 | 1.9 (1.0 to 2.9) | ||
| Other specified congenital anomalies of muscle tendon | <11 | 0.5 (−0.2 to 1.3) | 89 | 0.5 (0.4 to 0.6) | <11 | 0.4 (0.0 to 0.8) | ||
| Conotruncal malformations | ||||||||
| Tetralogy of Fallot | 18 | 4.8 (2.6 to 7.0) | 655 | 3.5 (3.2 to 3.8) | 41 | 5.0 (3.5 to 6.5) | ||
| Transposition of great vessels | 19 | 5.0 (2.8 to 7.3) | 718 | 3.8 (3.6 to 4.1) | 25 | 3.0 (1.9 to 4.2) | ||
| Oral clefts | ||||||||
| Cleft palate | 18 | 4.8 (2.6 to 7.0) | 1094 | 5.8 (5.5 to 6.2) | 43 | 5.2 (3.7 to 6.8) | ||
| Cleft lip | 14 | 3.7 (1.8 to 5.7) | 683 | 3.6 (3.4 to 3.9) | 29 | 3.5 (2.3 to 4.8) | ||
| Cleft palate with cleft lip | 13 | 3.5 (1.6 to 5.3) | 1042 | 5.6 (5.2 to 5.9) | 35 | 4.3 (2.9 to 5.7) | ||
Estimates are based on the entire cohort (before trimming observations from the non-overlapping regions of the propensity score distributions). Cell sizes less than 11 are suppressed according to the cell size suppression policy of the Centers for Medicare and Medicaid Services.