Table 1.
Carbimazole | Propylthiouracil | ||||||
---|---|---|---|---|---|---|---|
System | Congenital anomalies* | Number of anomalies (total) | Number with single anomaly | Number with other anomalies | Number of anomalies (total) | Number with single anomaly | Number with other anomalies |
Skin | Aplasia cutis | 6 | 2 | 4 | 0 | 0 | 0 |
Other (skin disorder, ulcer) | 2 | 0 | 2 | 0 | 0 | 0 | |
| |||||||
Respiratory | Choanal atresia | 5 | 2 | 3 | 0 | 0 | 0 |
Tracheo-oesophageal fistula | 2 | 2 | 0 | 0 | 0 | 0 | |
Other (neonatal respiratory distress syndrome, respiratory disorder) | 2 | 0 | 2 | 0 | 0 | 0 | |
| |||||||
Gastrointestinal | Cleft palate | 5 | 3 | 2 | 1 | 1 | 0 |
Omphalocele/umbilical abnormalities | 4 | 2 | 2 | 2 | 0 | 2 | |
Patent vitellointestinal duct | 1 | 0 | 1 | 0 | 0 | 0 | |
Duodenal atresia | 1 | 1 | 0 | 0 | 0 | 0 | |
Anal atresia | 1 | 0 | 1 | 0 | 0 | 0 | |
Other (neonatal jaundice and abnormal liver function tests) | 2 | 0 | 2 | 0 | 0 | 0 | |
Not specified | 3 | 2 | 1 | 0 | 0 | 0 | |
| |||||||
Cardiovascular | Septal defects | 3 | 1 | 2 | 0 | 0 | 0 |
Other (Fallot's tetralogy and coarctation of aorta) | 2 | 2 | 0 | 0 | 0 | 0 | |
Not specified | 1 | 0 | 1 | 0 | 0 | 0 | |
| |||||||
Musculoskeletal | Limb/hand/foot malformation | 4 | 1 | 3 | 3 | 1 | 2 |
Not specified | 4 | 3 | 1 | 0 | 0 | 0 | |
| |||||||
Neurological | Spina bifida | 3 | 1 | 2 | 0 | 0 | 0 |
Hydrocephalus | 5 | 1 | 4 | 0 | 0 | 0 | |
Anencephaly | 4 | 4 | 0 | 1 | 0 | 1 | |
Hypotonia | 2 | 0 | 2 | 0 | 0 | 0 | |
Other (spine malformation and holoprosencephaly) | 1 | 0 | 1 | 1 | 0 | 1 | |
| |||||||
Renal/urinary tract | Renal aplasia | 1 | 0 | 1 | 0 | 0 | 0 |
Other (urinary tract malformation, epispadias) | 1 | 0 | 1 | 1 | 1 | 0 | |
| |||||||
Endocrine | Thyroid disorder | 1 | 0 | 1 | 0 | 0 | 0 |
Hypogonadism | 1 | 0 | 1 | 0 | 0 | 0 | |
| |||||||
Craniofacial | Dysmorphic facies | 2 | 0 | 2 | 1 | 0 | 1 |
Skull malformation | 4 | 1 | 3 | 0 | 0 | 0 | |
Ear malformation | 3 | 1 | 2 | 0 | 0 | 0 | |
Deafness | 4 | 2 | 2 | 0 | 0 | 0 | |
Eye malformation | 4 | 1 | 3 | 0 | 0 | 0 | |
Other (nose malformation and teeth malformation) | 2 | 0 | 2 | 0 | 0 | 0 | |
| |||||||
Others | Nipple/breast anomalies (athelia and hypoplastic nipples) | 2 | 0 | 2 | 0 | 0 | 0 |
Developmental delay | 2 | 0 | 2 | 0 | 0 | 0 | |
Autism | 0 | 0 | 0 | 1 | 0 | 1 | |
Not specified | 7 | 1 | 6 | 0 | 0 | 0 | |
| |||||||
Total | 97 | 33 | 64 | 11 | 3 | 8 |
*One Yellow Card report may contain more than one reaction term. Therefore, the total number of reactions is greater than the total number of reports.