Table 1 Adverse events included in the MedDRA Query “Pregnancy and neonatal topics” that were identified during the case-by-case assessment of individual case safety reports.
From: Direct-acting oral anticoagulants (DOACs) in pregnancy: new insight from VigiBase®
DOAC | Number of cases without alternative causes for the adverse event | Number of cases with alternative causes for the adverse event | Total* |
|---|---|---|---|
Apixaban | |||
Induced abortion | 5 | 0 | 5 |
Pregnancy termination | 1 | 0 | 1 |
Spina bifida | 0 | 1 | 1 |
Dysmorphism | 0 | 1 | 1 |
Face malformation NOS | 0 | 1 | 1 |
Unspecified congenital anomaly of heart | 0 | 1 | 1 |
Congenital hydronephrosis | 0 | 1 | 1 |
Spontaneous abortion/miscarriage | 6 | 0 | 6 |
Fetal growth retardation | 0 | 1 | 1 |
Skeletal dysplasia | 0 | 1 | 1 |
Multiple epiphyseal dysplasia | 0 | 1 | 1 |
Fetal growth restriction | 0 | 1 | 1 |
Neonatal respiratory distress syndrome | 0 | 1 | 1 |
Skeletal malformation | 0 | 1 | 1 |
Congenital musculoskeletal anomaly | 0 | 1 | 1 |
Premature baby | 0 | 1 | 1 |
Chondrodystrophy | 0 | 1 | 1 |
Brachydactyly | 0 | 1 | 1 |
Uterus evacuation | 1 | 0 | 1 |
Abortion | 1 | 0 | 1 |
Abortion early | 1 | 0 | 1 |
Low birth weight baby | 1 | 0 | 1 |
Dabigatran | |||
Miscarriage | 0 | 1 | 1 |
Induced abortion | 1 | 0 | 1 |
Edoxaban | |||
Spontaneous abortion | 1 | 0 | 1 |
Rivaroxaban | |||
Intrauterine growth retardation/Low birth weight baby | 4 | 1 | 5 |
Spontaneous abortion/miscarriage | 9 | 14 | 23 |
Abortion | 1 | 0 | 1 |
Fetal heartbeat absent | 1 | 0 | 1 |
Congenital limb anomaly | 1 | 0 | 1 |
Fetal death | 1 | 0 | 1 |
Fetal heart rate deceleration | 1 | 0 | 1 |
Missed abortion | 0 | 1 | 1 |
Facial dysmorphism | 1 | 0 | 1 |
Oligohydramnios | 0 | 1 | 1 |
Ventricular hypoplasia | 0 | 1 | 1 |
Abortion (unspecified) | 0 | 1 | 1 |
Congenital cerebral cyst | 1 | 0 | 1 |
Congenital anomaly NOS | 0 | 1 | 1 |
Congenital cardiac septal defect | 0 | 1 | 1 |
Heart disease congenital | 0 | 1 | 1 |
Congenital cardiovascular anomaly | 0 | 1 | 1 |
Abortion early | 0 | 1 | 1 |
Post-abortion bleeding | 0 | 1 | 1 |
Induced abortion | 0 | 1 | 1 |
Premature delivery | 1 | 0 | 1 |
