ArticlePharmacoepidemiology and drug safety2016
Pregnancy outcomes following exposure to onabotulinumtoxinA.
Article in Pharmacoepidemiology and drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed.
- Long-Term Safety and Tolerability of OnabotulinumtoxinA Treatment in Patients with Chronic Migraine: Results of the COMPEL Study.Drug safety · 2019Trial
- Xenobiotic transfer of onabotulinumtoxinA using an ex vivo human placental perfusion model: A pilot study.Pregnancy (Hoboken, N.J.) · 2026Article
- The Management of Parkinson's Disease Before, during and after Pregnancy-an MDS Scientific Issues Committee Review.Movement disorders clinical practice · 2026Review
- Safety and tolerability of onabotulinumtoxinA in the treatment of upper facial lines from global registration studies in 5298 participants: A meta-analysis.JAAD international · 2024Article
- Efficacy and Safety Analysis of Botox Application and Iatrogenic Botulism: Panacea or Peril?Current pharmaceutical design · 2024Review
- Pregnancy Outcomes in Patients Exposed to OnabotulinumtoxinA Treatment: A Cumulative 29-Year Safety Update.Neurology · 2023Article
- Pharmacologic prevention of migraine.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2023Review
- Integrative, Interventional, and Non-invasive Approaches for the Treatment for Migraine During Pregnancy.Current pain and headache reports · 2022Review
- Safety of OnabotulinumtoxinA in the [management of] chronic migraine in pregnancy.Frontiers in pain research (Lausanne, Switzerland) · 2022Article
- OnabotulinumtoxinA for chronic migraine during pregnancy: a real world experience on 45 patients.The journal of headache and pain · 2020Article
- Ethics of esthetic procedures in pregnancy.International journal of women's dermatology · 2018Article
- Pregnancy outcomes following exposure to onabotulinumtoxinA.Pharmacoepidemiology and drug safety · 2016Article
- Clinician-Patient Dialogue About Preventive Chronic Migraine Treatment.Journal of primary care & community healthReview
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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