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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”