Table 4. Sensitivity Analyses of the Association Between Oral Terbinafine Use in Pregnancy and Risk of Major Malformations.
| Sensitivity Analyses | Oral Terbinafine Exposed | Comparison Group | Prevalence OR (95% CI) | ||
|---|---|---|---|---|---|
| Total No. of Pregnancies | Malformations, No. (%) | Total No. of Pregnancies | Malformations, No. (%) | ||
| Compared with unexposed pregnancies with recent oral terbinafine usea | 491 | 18 (3.7) | 971 | 31 (3.2) | 1.15 (0.64-2.08) |
| Oral terbinafine-exposed pregnancies compared with unexposed pregnancies | |||||
| Filled prescription in gestational weeks 4-10 | 130 | 5 (3.8) | 5220 | 198 (3.8) | 1.02 (0.41-2.51) |
| Exposure anytime during entire pregnancy | 613 | 23 (3.8) | 6130 | 227 (3.7) | 1.01 (0.66-1.57) |
| Exposure in 2nd and 3rd trimester only | 91 | 3 (3.3) | 6130 | 227 (3.7) | 0.89 (0.28-2.82) |
| Accumulative terbinafine dose >7000 mgb | 220 | 11 (5.0) | 5220 | 198 (3.8) | 1.08 (0.55-2.14) |
| Singleton pregnancies only | 511 | 19 (3.7) | 5097 | 193 (3.8) | 0.98 (0.61-1.59) |
| Filled prescription in gestational day 0-84 | 363 | 13 (3.6) | 5220 | 198 (3.8) | 0.94 (0.53-1.67) |
Abbreviation: OR, odds ratio.
a
Oral terbinafine-exposed pregnancies compared to pregnancies with oral terbinafine use in the last year prior to pregnancy only, matched in 1:2 ratio.
b
The median of the accumulative dose of oral terbinafine within the first trimester.