title: Pregnancy outcomes following exposure to onabotulinumtoxinA.
abstract: OBJECTIVE
  To evaluate pregnancy outcomes following onabotulinumtoxinA (US Food and Drug Administration pregnancy category C product) exposure using the Allergan safety database.
  
  
  METHODS
  The 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.
  
  
  RESULTS
  Of 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.
  
  
  CONCLUSIONS
  A 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.
authors.affiliation: Allergan, Inc., Irvine, CA, USA.|University of California, Irvine, CA, USA.
authors.forename: Mitchell F
authors.initials: MF
authors.lastname: Brin
authors.affiliation: University of South Florida, Tampa, FL, USA.
authors.forename: Russell S
authors.initials: RS
authors.lastname: Kirby
authors.affiliation: University of California, San Francisco, CA, USA.
authors.forename: Anne
authors.initials: A
authors.lastname: Slavotinek
authors.affiliation: Allergan, Inc., Irvine, CA, USA.
authors.forename: Mary Ann
authors.initials: MA
authors.lastname: Miller-Messana
authors.affiliation: Allergan, Inc., Irvine, CA, USA.
authors.forename: Lori
authors.initials: L
authors.lastname: Parker
authors.affiliation: Allergan, Inc., Irvine, CA, USA.
authors.forename: Irina
authors.initials: I
authors.lastname: Yushmanova
authors.affiliation: Allergan, Inc., Irvine, CA, USA.|Now at the Department of Drug Safety and Pharmacovigilance, Pharmacyclics, Inc., Sunnyvale, CA, USA.
authors.forename: Huiying
authors.initials: H
authors.lastname: Yang
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000175:diagnosis / Q000453:epidemiology*; D000022:Abortion, Spontaneous / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology*; D065087:Acetylcholine Release Inhibitors / Q000009:adverse effects; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000639:trends; D019274:Botulinum Toxins, Type A / Q000009:adverse effects*; D016208:Databases, Factual / Q000639:trends; D005260:Female; D006801:Humans; D050498:Live Birth / Q000453:epidemiology*; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology; D011297:Prenatal Exposure Delayed Effects / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology*; D011446:Prospective Studies; D012189:Retrospective Studies
chemical_list: D065087:Acetylcholine Release Inhibitors; D019274:Botulinum Toxins, Type A
keywords: fetal defects; onabotulinumtoxinA; pharmacoepidemiology; pregnancy