Birth defects reported in pharmacovigilance database
| Case | Event | Approximate trimester exposure | Infant sex | Maternal age, years | Comments |
|---|---|---|---|---|---|
| 1 | Ventriculoseptal defect, patent ductus arteriosus and foramen ovale, hip dysplasia | 1 | Female | 23 | Concomitant medication (first trimester): sertraline |
| 2 | Congenital hernia in the groin | 1 | Male | 31 | Interferon beta-1b stopped during first trimester. The patient was treated with glatiramer acetate during pregnancy. Born at 39 gestational weeks. Weight was 2.45 kg (5 lbs 6 oz—considered “low weight”) and 49 cm (19.3 inch) The physician attributes hernia to the fact that the child was born “by his foot” and was pulled out during the delivery |
| 3 | Ectopic kidney, agenesis, renal dysgenesis, obstructive congenital abnormalities to the renal pelvis and ureter | 1 | Male | 36 | Term delivery |
| 4 | Spina bifida, hydrocephalus and clubfeet | 1 | Male | 29 | The patient was primiparous. Concurrent medical conditions included body mass index of 40.8 (weight: 260 lbs, height: 5 feet 7 inch) and hypertension. Concomitant medications included nifedipine, ascorbic acid, thiamine, cyanocobalamin, retinol, riboflavin and calcium (prenatal). The patient's second child was healthy |
| 5 | Capillary haemangioma (parietal area and left third toe. Both measured 0.5 cm in size) | 1 | Male | 27 | Urinary tract infection during pregnancy treated with 2 capsules of nitrofurantoin |
| 6 | Right eye has line from iris noted, at fourth month: no birth defects | 1 | Male | 26 | Concomitant conditions included depression and bipolar disorder (diagnosed preconception). Concomitant medication was given. Previous pregnancies (3) resulted in spontaneous abortions |
| 7 | Pilonidal dimple without sinus | 1 | Male | 30 | Previous pregnancies resulted in 1 spontaneous abortion and 1 male infant with ambiguous genitalia |
| 8 | Polydactylia (postaxial digit, contains only soft tissue without a nail and measured approximately 1 cm) | 1 | Male | 25 | Pregnancy history included 1 live birth with no history of birth defects or maternal complications. Concomitant medications included prenatal vitamins for pregnancy At-term delivery |