Table 5.
Association between study medication exposures during the 1st trimester of pregnancy and the risk of organ-specific system malformations.
| Nervous system malformations | ||||
| Yes | No | Crude RR | Adjusteda RR | |
| n = 1,376 | n = 232,524 | (95% CI) | (95% CI) | |
| n (%) | ||||
| Study medication exposure during the 1st trimester of pregnancy: | ||||
| Triptansb | 5 (0.36) | 462 (0.20) | 1.68 (0.70-4.02) | 1.32 (0.55-3.21) |
| Eye, ear, face and neck malformations | ||||
| Yes | No | Crude RR | Adjusteda RR | |
| n = 1,087 | n=232,813 | (95% CI) | (95% CI) | |
| Study medication exposure during the 1st trimester of pregnancy: | ||||
| Triptansb | 2 (0.18) | 465 (0.20) | 0.89 (0.22-3.58) | 0.85 (0.22-3.67) |
| Patent ductus malformations | ||||
| Yes | No | Crude RR | Adjusteda RR | |
| n = 962 | n=232,938 | (95% CI) | (95% CI) | |
| Study medication exposure during the 1st trimester of pregnancy: | ||||
| DHEc | 1 (0.10) | 77 (0.03) | 3.23 (0.39-26.69) | N.A. |
| Triptansb | 3 (0.31) | 464 (0.20) | 1.45 (0.47-4.48) | 1.06 (0.34-3.32) |
| Circulatory system malformations including heart defects | ||||
| Yes | No | Crude RR | Adjusted* RR | |
| n=5,251 | n=228,649 | (95% CI) | (95% CI) | |
| Study medication exposure during the 1st trimester of pregnancy: | ||||
| DHEc | 6 (0.11) | 72 (0.03) | 3.61 (0.91-14.30) | 3.29 (0.89-12.14) |
| Triptansb | 6 (0.11) | 461 (0.20) | 0.52 (0.23-1.18) | 0.41 (0.18-0.93) |
| Respiratory system malformations | ||||
| Yes | No | Crude RR | Adjusted* RR | |
| n=1,777 | n=232,723 | (95% CI) | (95% CI) | |
| Study medication exposure during the 1st trimester of pregnancy: | ||||
| Triptansb | 3 (0.25) | 464 (0.20) | 1.15 (0.36-3.66) | 0.80 (0.25-2.50) |
| Orofacial clefts malformations | ||||
| Yes | No | Crude RR | Adjusteda RR | |
| n=361 | n=233,539 | (95% CI) | (95% CI) | |
| Study medication exposure during the 1st trimester of pregnancy: | ||||
| DHEc | 0 | N.A. | N.A. | N.A. |
| Triptansb | 0 | N.A. | N.A. | N.A. |
| Gastrointestinal malformations | ||||
| Yes | No | Crude RR | Adjusted* RR | |
| n=1,713 | n=232,187 | (95% CI) | (95% CI) | |
| Study medication exposure during the 1st trimester of pregnancy: | ||||
| Triptansb | 9 (0.53) | 458 (0.20) | 2.43 (1.25-4.74) | 2.04 (1.01-4.11) |
| Genital system malformations | ||||
| Yes | No | Crude RR | Adjusted* RR | |
| n=1,783 | n=232,117 | (95% CI) | (95% CI) | |
| Study medication exposure during the 1st trimester of pregnancy: | ||||
| Triptansb | 4 (0.22) | 463 (0.20) | 1.11 (0.41-3.00) | 0.99 (0.37-2.69) |
| Urinary system malformations | ||||
| Yes | No | Crude RR | Adjusted* RR | |
| n=2,015 | n=231,885 | (95% CI) | (95% CI) | |
| Study medication exposure during the 1st trimester of pregnancy: | ||||
| Triptansb | 8 (0.40) | 459 (0.20) | 2.00 (1.00-4.03) | 1.61 (0.79-3.27) |
| Musculoskeletal system malformations | ||||
| Yes | No | Crude RR | Adjusted* RR | |
| n=10,568 | n=223,332 | (95% CI) | (95% CI) | |
| Study medication exposure during the 1st trimester of pregnancy: | ||||
| Triptansb | 21 (0.20) | 46 (0.20) | 0.94 (0.61-1.46) | 0.86 (0.55-1.34) |
aAdjusted for all variables included in the previous table.
bIncluding almotriptan, eletriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan; cDihydroergotamine.
Pregnant women can use more than 1 study medication during pregnancy.