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Table 4 Major and minor birth defects with possible temporal relationshipa to exposure

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

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

  1. Abbreviations: LMP last menstrual period, NA not applicable, NR not reported
  2. 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”