Table 3.
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.