Table 1.
Selected Characteristics of High Causality Pregnancy-associated DILI Cases
| Case # | Age (y) | Race/Ethnicity | Implicated Drug | DILI Onset | Weeks Gestation at onset | Pattern of Injury | Causality Score | Severity Score | Maternal Outcome | Fetal Outcome | Peak ALT U/L | Peak TB mg/dL |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 43 | W | Methyldopa | Pregnancy | 10 | HC | Definite | Moderate Hospitalized | Resolution | Unknown | 2459 | 11 |
| 2 | 29 | B | Methyldopa | Pregnancy | 20 | HC | Highly Likely | Mild | Resolution | Miscarriage | 800 | 0.8 |
| 3 | 30 | B | Methyldopa | Pregnancy | 8 | HC | Highly Likely | Moderate Hospitalized | Resolution | Unknown | 1315 | 17.8 |
| 4 | 24 | B | Infliximab | Pregnancy | 22 | HC | Highly Likely | Severe | Resolution | Delivered | 1155 | 25.41 |
| 5 | 20 | W | Quetiapine | Pregnancy | 29 | HC | Highly Likely | Mild | Resolution | Delivered | 1078 | 0.4 |
| 6 | 34 | H | Isoniazid | Pregnancy | 1st trimester | HC | Probable | Severe/Fatal | Transplant | Miscarriage | 2095 | 13.8 |
| 7 | 28 | W | Letrozole | Pregnancy | NA | HC | Probable | Moderate | Resolution | Miscarriage | 827 | 7 |
| 8 | 28 | B | Methyldopa | Postpartum | - | HC | Highly Likely | Severe | Resolution | Delivered | 579 | 21.7 |
| 9 | 20 | W | OCP | Postpartum | - | HC | Highly Likely | Moderate Hospitalized | Resolution | Delivered | 445 | 14.9 |
| 10 | 32 | H | Methyldopa | Postpartum | - | HC | Definite | Severe | Resolution | Delivered | 1415 | 29.9 |
| 11 | 28 | W | Cefazolin | Postpartum | - | C | Highly Likely | Moderate Hospitalized | Resolution | Terminated | 201 | 7.3 |
| 12 | 25 | B | Methyldopa | Postpartum | - | HC | Highly Likely | Moderate Hospitalized | Resolution | Delivered | 1292 | 24.9 |
| 13 | 39 | B | Methyldopa | Postpartum | - | HC | Highly Likely | Moderate Hospitalized | Resolution | Delivered | 1414 | 19.5 |
| 14 | 26 | W | Methyldopa | Postpartum | - | HC | Highly Likely | Moderate Hospitalized | Resolution | Delivered | 1577 | 15.3 |
| 15 | 31 | H | PTU | Pregnancy | 36 | M | Probable | Severe | Resolution | Delivered | 549 | 8.4 |
| 16 | 31 | B | Methyldopa | Pregnancy | 11 | HC | Probable | Moderate Hospitalized | Unknown | Unknown | 1481 | 3.2 |
Definite causality score corresponds to >95% likelihood, high likely= 70-95%, probable= 50-<70%. Abbreviations: W=White, B=Black, H= Hispanic, HC=Hepatocellular, C=Cholestatic, PTU=propylthiouracil; OCP, oral contraceptive pills.