Evidence map›Paper›PMID 37137724›Full record

ArticleNeurology2023

Pregnancy Outcomes in Patients Exposed to OnabotulinumtoxinA Treatment: A Cumulative 29-Year Safety Update.

Mitchell F Brin, Russell S Kirby, Anne Slavotinek, Aubrey Manack Adams, Lori Parker, Ahunna Ukah, Lavinia Radulian, Monica R P Elmore, Larisa Yedigarova, Irina Yushmanova

Erratum issuedOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
7.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Review
  6. Sex-specific considerations in migraine therapy.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Migraine and Pregnancy.Life (Basel, Switzerland) · 2024
    Article
  14. Review
  15. Review
  16. Article
  17. Health equity, care access and quality in headache - part 2.The journal of headache and pain · 2023
    Review
  18. Botulinum Toxin Treatment in Pregnant Laryngeal Dystonia Patients: Case Series and Survey of Current Practice of Canadian Laryngologists.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 2 countries.

Mitchell F BrinFrom Allergan, an AbbVie Company (M.F.B., A.M.A., L.P., A.U., M.R.P.E., L.Y., I.Y.), Irvine, CA; Department of Neurology (M.F.B.), University of California, Irvine; College of Public Health (R.S.K.), University of South Florida, Tampa; Division of Medical Genetics (A.S.), Department of Pediatrics, University of California, San Francisco; Allergan, an AbbVie Company (L.R.); and University of Medicine and Pharmacy (L.R.), Carol Davila, Bucharest, Romania. mitchell.brin@abbvie.com.
Russell S KirbyFrom Allergan, an AbbVie Company (M.F.B., A.M.A., L.P., A.U., M.R.P.E., L.Y., I.Y.), Irvine, CA; Department of Neurology (M.F.B.), University of California, Irvine; College of Public Health (R.S.K.), University of South Florida, Tampa; Division of Medical Genetics (A.S.), Department of Pediatrics, University of California, San Francisco; Allergan, an AbbVie Company (L.R.); and University of Medicine and Pharmacy (L.R.), Carol Davila, Bucharest, Romania.ORCID 0000-0002-3489-401X
Anne SlavotinekFrom Allergan, an AbbVie Company (M.F.B., A.M.A., L.P., A.U., M.R.P.E., L.Y., I.Y.), Irvine, CA; Department of Neurology (M.F.B.), University of California, Irvine; College of Public Health (R.S.K.), University of South Florida, Tampa; Division of Medical Genetics (A.S.), Department of Pediatrics, University of California, San Francisco; Allergan, an AbbVie Company (L.R.); and University of Medicine and Pharmacy (L.R.), Carol Davila, Bucharest, Romania.
Aubrey Manack AdamsFrom Allergan, an AbbVie Company (M.F.B., A.M.A., L.P., A.U., M.R.P.E., L.Y., I.Y.), Irvine, CA; Department of Neurology (M.F.B.), University of California, Irvine; College of Public Health (R.S.K.), University of South Florida, Tampa; Division of Medical Genetics (A.S.), Department of Pediatrics, University of California, San Francisco; Allergan, an AbbVie Company (L.R.); and University of Medicine and Pharmacy (L.R.), Carol Davila, Bucharest, Romania.
Lori ParkerFrom Allergan, an AbbVie Company (M.F.B., A.M.A., L.P., A.U., M.R.P.E., L.Y., I.Y.), Irvine, CA; Department of Neurology (M.F.B.), University of California, Irvine; College of Public Health (R.S.K.), University of South Florida, Tampa; Division of Medical Genetics (A.S.), Department of Pediatrics, University of California, San Francisco; Allergan, an AbbVie Company (L.R.); and University of Medicine and Pharmacy (L.R.), Carol Davila, Bucharest, Romania.
Ahunna UkahFrom Allergan, an AbbVie Company (M.F.B., A.M.A., L.P., A.U., M.R.P.E., L.Y., I.Y.), Irvine, CA; Department of Neurology (M.F.B.), University of California, Irvine; College of Public Health (R.S.K.), University of South Florida, Tampa; Division of Medical Genetics (A.S.), Department of Pediatrics, University of California, San Francisco; Allergan, an AbbVie Company (L.R.); and University of Medicine and Pharmacy (L.R.), Carol Davila, Bucharest, Romania.
Lavinia RadulianFrom Allergan, an AbbVie Company (M.F.B., A.M.A., L.P., A.U., M.R.P.E., L.Y., I.Y.), Irvine, CA; Department of Neurology (M.F.B.), University of California, Irvine; College of Public Health (R.S.K.), University of South Florida, Tampa; Division of Medical Genetics (A.S.), Department of Pediatrics, University of California, San Francisco; Allergan, an AbbVie Company (L.R.); and University of Medicine and Pharmacy (L.R.), Carol Davila, Bucharest, Romania.
Monica R P ElmoreFrom Allergan, an AbbVie Company (M.F.B., A.M.A., L.P., A.U., M.R.P.E., L.Y., I.Y.), Irvine, CA; Department of Neurology (M.F.B.), University of California, Irvine; College of Public Health (R.S.K.), University of South Florida, Tampa; Division of Medical Genetics (A.S.), Department of Pediatrics, University of California, San Francisco; Allergan, an AbbVie Company (L.R.); and University of Medicine and Pharmacy (L.R.), Carol Davila, Bucharest, Romania.
Larisa YedigarovaFrom Allergan, an AbbVie Company (M.F.B., A.M.A., L.P., A.U., M.R.P.E., L.Y., I.Y.), Irvine, CA; Department of Neurology (M.F.B.), University of California, Irvine; College of Public Health (R.S.K.), University of South Florida, Tampa; Division of Medical Genetics (A.S.), Department of Pediatrics, University of California, San Francisco; Allergan, an AbbVie Company (L.R.); and University of Medicine and Pharmacy (L.R.), Carol Davila, Bucharest, Romania.
Irina YushmanovaFrom Allergan, an AbbVie Company (M.F.B., A.M.A., L.P., A.U., M.R.P.E., L.Y., I.Y.), Irvine, CA; Department of Neurology (M.F.B.), University of California, Irvine; College of Public Health (R.S.K.), University of South Florida, Tampa; Division of Medical Genetics (A.S.), Department of Pediatrics, University of California, San Francisco; Allergan, an AbbVie Company (L.R.); and University of Medicine and Pharmacy (L.R.), Carol Davila, Bucharest, Romania.
Allergan (Ireland) · IEAbbVie (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesA previous publication of pregnancy outcomes in onabotulinumtoxinA-exposed mothers demonstrated that the prevalence of major fetal defects (0.9%, 1/110) was comparable with background rates in the general population. There is continued interest to better understand the safety of onabotulinumtoxinA during pregnancy. This analysis evaluated pregnancy outcomes after onabotulinumtoxinA exposure to provide a cumulative 29-year update.

methodsThe Allergan Global Safety Database was searched from January 1, 1990, to December 31, 2018. Data from women (younger than 65 years or unknown) during pregnancy or ≤3 months before conception treated with onabotulinumtoxinA were assessed to estimate birth defect prevalence rates of live births only from prospective pregnancies.

resultsOf 913 pregnancies, 397 (43.5%) were eligible with known outcomes. Maternal age was known in 215 pregnancies: 45.6% were 35 years or older. Indication was known in 340 pregnancies: most frequent were aesthetic (35.3%) and migraine/headache (30.3%). The timing of exposure was known in 318 pregnancies: 94.6% were before conception or during the first trimester. OnabotulinumtoxinA dose information was known in 242 pregnancies; most (83.5%) were exposed to <200 U. Of 195 prospective pregnancies with 197 fetuses, there were 152 (77.2%) live births and 45 (22.8%) fetal losses (32 spontaneous, 13 elective). Of 152 live births, 148 (97.4%) had normal outcomes and 4 had abnormal outcomes. Among the 4 abnormal outcomes, there were 1 major birth defect, 2 minor fetal defects, and 1 birth complication. The prevalence rate for overall fetal defects was 2.6% (4/152, 95% CI 1.0%-6.6%) and 0.7% (1/152, 95% CI 0.1%-3.6%) for major fetal defects (3%-6% in the general population). Among cases of live births and known determinable exposure times, there was 1 birth defect with preconception exposure and 2 with first-trimester exposure. DISCUSSION: Although subject to reporting bias due to the nature of the postmarketing database review, this 29-year retrospective analysis of safety data in pregnant women exposed to onabotulinumtoxinA demonstrates that the prevalence rate of major fetal defects among live births is consistent with the rates reported in the general population. Although there are limited data available for second-trimester and third-trimester exposure, this updated and expanded safety analysis provides important real-world evidence to health care providers and their patients. CLASSIFICATION OF EVIDENCE: This analysis provides Class III data that demonstrate that the prevalence rate of major fetal defects among live births subsequent to in utero onabotulinumtoxinA exposure is comparable with the reported background rates.

Indexed as

Botulinum Toxins, Type APregnancy OutcomeAdultFemaleHumansLive BirthPregnancyProspective StudiesRetrospective StudiesBotulinum Toxins, Type A

Identifiers

PMID37137724
PMCPMC10351549
OpenAlexW4367836762

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.