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Table 3 All observed major and minor birth defects (per MACDP criteria [25]) by organ system

From: Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: a global, observational, follow-up study

Organ system, birth defect Major or minor birth defect Number of events (n = 57)
Musculoskeletal (n = 11)
 Plagiocephalya Minor 4
 Torticollisa Major 4
 Hip dysplasia Major 1
 Polydactyly Major 1
 Absent right femur Major 1
Cardiovascular (n = 10)
 Ventricular septal defectb Major 3
 Patent foramen ovalec Minor 2
 Atrial shunt Major 1
 Patent ductus arteriosusc Minor 1
 Supraventricular tachycardia Minor 1
 Tetralogy of Fallot Major 1
 Tricuspid valve atresia Major 1
Skin (n = 9)
 Hemangioma Minor 2
 Café-au-lait spot Minor 1
 Irregular tragus Minor 1
 Mongolian spot Minor 1
 Small anterior fontanelle Minor 1
 Subcutaneous cyst Minor 1
 Unspecified anomaly of nose Major 1
 Unspecified anomaly of toes Minor 1
Genital disorders (n = 8)
 Chordee Minor 2
 Hydrocele Minor 2
 Undescended testicle Minor 2
 Chordee with hypospadias Major 1
 Penile concealment Major 1
Neurologic (n = 6)
 Colpocephaly Major 1
 Holoprosencephaly Major 1
 Hydrocephalus Major 1
 Myelomeningocele Major 1
 Sacral dimple Minor 1
 Unspecified agenesis of corpus callosum Major 1
Renal (n = 5)
 Hydronephrosis Major 2
 Cystic dysplasia Major 1
 Renal dilation Minor 1
 Vesicoureteral reflux Major 1
Gastrointestinal (n = 4)
 Umbilical hernia Minor 2
 Inguinal hernia Minor 1
 Tight frenulum Minor 1
Chromosome (n = 1)
 Partial trisomy 9d Major 1
Endocrine (n = 1)
 Congenital hypothyroidism Minor 1
Metabolic (n = 1)
 Phenylketonuria Major 1
Ocular (n = 1)
 Disconjugate gaze Major 1
  1. aThree cases of plagiocephaly and 2 cases of torticollis occurred in 2 sets of twins
  2. bNo cases occurred in a premature birth (i.e., <37 weeks)
  3. cOne case occurred in a premature birth (35 weeks 4 days’ gestation)
  4. dMaternal age was 46 years at enrollment