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. 2015 Dec 4;25(2):179–187. doi: 10.1002/pds.3920

Table 3.

Summary of fetal defects in prospective and retrospective cases of live births and abortions

Adverse event Outcome BOTOX indication Time of exposure BOTOX dose Maternal age
Prospective fetal defects in live births
Major fetal defects (n = 1)
Ventricular septal defect C‐section; asymptomatic, no intervention required Axillary hyperhidrosis 37 days pre‐conception 100U 28 years
Minor fetal malformations (n = 2)
Metatarsus adductus Induced vaginal delivery (decreased fetal movement); no other abnormalities Chronic migraine 15 days post‐conception 155U 19 years
Innocent asymptomatic cardiac murmur* Family history of cardiac murmur Blepharospasm Trimesters 1, 2, 3 8U, 12U, 14U 23 years
Birth complication (n = 1)
Horner syndrome C‐section, placenta previa, and uterine varicosities; no abnormalities reported 11 months later Axillary hyperhidrosis “Few days” before conception 100U (50U each axilla) Unknown
Prospective fetal defect in abortions
Genetic abnormalities (n = 1)
Down syndrome Miscarriage at gestation month 5 Skin wrinkling (glabella) 40 days post‐conception 12U 38 years
Retrospective fetal defects in live births
Major fetal defects (n = 1)
Tracheoesophageal fistula, esophagealatresia Pre‐term labor at ~33 weeks resulting in C‐section; surgical repair successful Facial wrinkles 3 days post‐conception 36U 30 years
Minor fetal malformations (n = 1)
Laryngomalacia Planned C‐section at 38 weeks; settled spontaneously over several months Facial wrinkles 1 week pre‐conception and 2 weeks post‐conception Not reported 38 years
Significant adverse event (n = 1)
Brain tumor (unspecified) Successful surgical resection Cervical dystonia Within 1 week before conception 100U 25 years
Retrospective fetal defects in abortions
Genetic abnormality (n = 1)
Down syndrome Elective abortion at week 20 Skin wrinkling (glabella) “Immediately after injection” 25U 40 years
*

Diagnosed at 7 days.

Diagnosed at 13 months.