Abstract
PurposeTo evaluate pregnancy outcomes following onabotulinumtoxinA (US Food and Drug Administration pregnancy category C product) exposure using the Allergan safety database.MethodsThe Allergan Global Safety Database contains reports of onabotulinumtoxinA administration before/during pregnancy, including both prospective (reported before outcome) and retrospective (outcome already known) cases. The database was searched from 1/1/90 to 12/31/13 for eligible cases where treatment occurred during pregnancy or ≤3 months before conception. To minimize reporting bias, prevalence rates were focused on prospective cases.ResultsOf 574 pregnancies with maternal onabotulinumtoxinA exposure, 232 were eligible with known outcomes. Patients received onabotulinumtoxinA most frequently for cosmetic indications (50.5%), movement disorders (16.8%), and pain disorders (14.2%). Of the 137 with dose information, 40.1% received <50U, 14.6% 50U to <100U, 27.7% 100U to <200U, and 17.5% ≥200U. Among 146 cases with known maternal age, 47.9% were ≥35 years. Most (96.0%) fetal exposures occurred during/before the first trimester. Of the 137 prospective cases (139 fetuses), 110 (79.1%) were live births; 29 (20.9%; 95% CI, 14.0–30.0%) ended in fetal loss (21 spontaneous, 8 induced abortions). Among live births, 106 (96.4%) were normal, with four abnormal birth outcomes (1 major fetal defect, 2 minor fetal malformations, 1 birth complication), giving a 2.7% (3/110; 95% CI, 0.6–8.0%) prevalence rate for overall fetal defects.ConclusionsA 24‐year retrospective review of the Allergan safety database shows that the prevalence of fetal defects in onabotulinumtoxinA‐exposed mothers before/during pregnancy (2.7%) is comparable with background rates in the general population. Pregnancy outcome monitoring in onabotulinumtoxinA‐exposed women continues. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
Highlights
OnabotulinumtoxinA (BOTOX®/BOTOX® Cosmetic, Allergan, Inc., Irvine, CA) has been studied and marketed globally for a variety of indications for over 20 years
OnabotulinumtoxinA is designated as a US Food and Drug Administration (FDA) pregnancy category
This database contains individual case safety reports received from pre- and post-approval sources, including Allergan-sponsored and partner-sponsored clinical trials, spontaneous sources, post-authorization studies, health authorities, and published literature
Summary
OnabotulinumtoxinA (BOTOX®/BOTOX® Cosmetic, Allergan, Inc., Irvine, CA) has been studied and marketed globally for a variety of indications for over 20 years. In the USA, approved indications for onabotulinumtoxinA include strabismus, blepharospasm, cervical dystonia, axillary hyperhidrosis, chronic migraine, upper limb spasticity, neurogenic detrusor overactivity, overactive bladder, and the cos-. Metic indications of glabellar lines and lateral canthal lines (Table 1).[1,2] OnabotulinumtoxinA is indicated for use in adults in the USA, except for the treatment of blepharospasm and strabismus, in which it is indicated for patients ≥12 years of age. Over the past 24 years (1990–2014), approximately 54 million vials of BOTOX® and BOTOX® Cosmetic have been distributed worldwide (Allergan data on file). OnabotulinumtoxinA is designated as a US Food and Drug Administration (FDA) pregnancy category. While women who are pregnant, nursing, or planning a pregnancy are excluded m. f. brin et al
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