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Fetal and birth defects: 6 case reports In a study conducted between 1 January 1990 and 31 December 2018 evaluating pregnancy outcomes following onabotulinumtoxin A exposure using the Allergan safety database, five fetuses and one neonate [ages not stated] were described, who developed ventricular septal defect, heart disease congenital (possible hole in heart), metatarsus adducts, asymptomatic cardiac murmur, corpus callosum agenesis or horner’s syndrome following in-utero exposure to botulinum toxin-a. The mother’s received botulinum toxin-a [onabotulinumtoxin A] at 37 days pre-conception (1 woman), trimester 1 (1 woman), 15 days post conception (1 woman), trimesters 1, 2 and 3 (1 woman), 4 days post-conception (1 woman) and few days prior to conception (1 woman) for unknown indication, axillary hyperhidrosis, an unspecified skin cosmetic procedure, chronic migraine or blepharospasm. The doses of botulinum toxin-a in 4 mothers ranged from 8U–155U and was unknown in the remaining two mothers [routes not stated; not all dosages stated]. Subsequently, the fetuses developed ventricular septal defect (1 fetus), heart disease congenital (possible hole in heart; 1 fetus), metatarsus adducts (1 fetus), asymptomatic cardiac murmur (1 fetus) and corpus callosum agenesis (1 fetus), while one neonate developed Horner’s syndrome as a birth complication. The mother of the fetus (the fetus who had ventricular septal defect), underwent C-section, and the intervention for ventricular septal defect was not required. The mother of the fetus (the fetus who had metatarsus adducts), underwent induced vaginal delivery. The neonate’s mother underwent C-section, and no abnormalities were detected in the neonate after 11 months [time to reactions onsets not stated; not all outcomes stated]. Brin M, et al. Pregnancy outcomes following exposure to onabotulinumtoxina update-29 years of safety observation. Headache 60 (Suppl. 1): 128-129, Jun 2020. Available from: URL: http://doi.org/10.1111/head.13854 [abstract] 803501113

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Reactions 12 Sep 2020 No. 1821