Table 5.
Suspected drugs and adverse drug reaction (ADR) terms in the reports where congenital anomaly was reported as the seriousness criterion in Turkey between 2005 and 2013
| Case | Suspected drug | ADR terms |
|---|---|---|
| 1 | Adalimumab | Maternal exposure during pregnancy; abortion |
| 2 | Adefovir dipivoxil | Congenital anomaly, third finger first phalanx deficiency |
| 3 | Butamirate citrate | Dysmorphism; alopecia areata; hypotonia; mental retardation; failure to thrive; brain malformation; congenital deafness; congenital blindness |
| 4 | Dasatinib | Flatulence; maternal exposure during pregnancy |
| 5 | Drospirenone/ethinylestradiol | Therapeutic abortion due to anomaly |
| 6 | Entecavir | Congenital musculoskeletal anomaly |
| 7 | Escitalopram, mirtazapine, hyoscine n-butylbromide, medazepam | Maternal exposure during pregnancy; congenital anomaly not otherwise specified, abnormality of right forearm reduction of the fetus |
| 8 | Insulin aspart | Congenital anomaly (5-alfa reductase enzyme deficiency dependent ambiguous genitalia, left coronary artery variation anomaly and horse-shoe kidney) |
| 9 | Insulin regular/insulin isophane | Maternal exposure during pregnancy; congenital hand malformation; limb malformation |
| 10 | Insulin regular/insulin isophane | Premature baby; breech presentation; fetal exposure during pregnancy |
| 11 | Isotretinoin | Congenital hydrocephalus; eyelid ptosis; cleft palate; ear malformation |
| 12 | Olanzapine | Maternal exposure during pregnancy; hypotonia neonatal; cyanosis neonatal; talipes |
| 13 | Ranibizumab | Ventricular septal defect |
| 14 | Tenofovir disoproxil fumarate | Premature baby; fetal death; placental disorder |