Table 4.
Major and minor birth defects with possible temporal relationshipa to exposure
| Major birth defects | Minor birth defects | Gestational age at last natalizumab dose | Maternal concomitant medications |
|---|---|---|---|
| Absent right femur | NA | 4 weeks | Azelastine nasal, prenatal vitamins, zolpidem |
| Anomaly of nose, cystic dysplasia of kidney, holoprosencephaly | Sandal toe gap, small anterior fontanelle | 3 weeks | Methylphenidate, prenatal vitamins |
| Atrial shunt | NA | 1 week | Heparin sodium, prenatal vitamins |
| Chordee with hypospadias | NA | 26 days | Fluvoxamine, hydrocodone/acetaminophen, lamotrigine, meperidine/promethazine, ondansetron hydrochloride, prenatal vitamins |
| Colpocephaly, hydrocephalus, partial agenesis of corpus callosum | NA | 4 days | Methylprednisolone sodium succinate, sertraline hydrochloride |
| Hydronephrosis | NA | 5 weeks | Levothyroxine, metformin, sertraline hydrochloride |
| Penile concealment | NA | 3 weeks | Prenatal vitamins |
| Polydactyly | NA | 5 days | Folic acid, insulin |
| Tetralogy of Fallot | NA | 0 (29 days prior to LMP) | Duloxetine, prenatal vitamins, topiramate, trazodone |
| Torticollis | NA | 8 weeks | Bupropion, methylprednisolone, pantoprazole, propoxyphene/ acetaminophen, topiramate |
| Tricuspid valve atresia | NA | 3 weeks | NR |
| Ventricular septal defect | NA | 1 day | NR |
| NA | Congenital hypothyroidism | 4.5 weeks | Nitrofurantoin, prenatal vitamins, Rh0(D) immune globulin, venlafaxine hydrochloride |
| NA | Irregular tragus, umbilical hernia | 11 weeks | Prenatal vitamins |
| NA | Mongolian spot | 3 weeks | Escitalopram, hydrocodone, levothyroxine, modafinil, prenatal vitamins |
| NA | Sacral dimple, umbilical hernia | 5 weeks | Prenatal vitamins, valacyclovir |
| NA | Subcutaneous cyst | 3 weeks | Prenatal vitamins |
| NA | Tight frenulum | 3 days | Prenatal vitamins, tizanidine |
Abbreviations: LMP last menstrual period, NA not applicable, NR not reported
aPotential relevance of the timing of natalizumab exposure to the birth defect(s) was evaluated and coded by the geneticist as “known cause”, “unknown cause”, “no association”, or “possible association”