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. 2023 Jul 11;101(2):e103-e113.
doi: 10.1212/WNL.0000000000207375. Epub 2023 May 3.

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

Mitchell F Brin  1 , Russell S Kirby  2 , Anne Slavotinek  2 , Aubrey Manack Adams  2 , Lori Parker  2 , Ahunna Ukah  2 , Lavinia Radulian  2 , Monica R P Elmore  2 , Larisa Yedigarova  2 , Irina Yushmanova  2
Affiliations

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

Mitchell F Brin et al. Neurology. .

Erratum in

Abstract

Background and objectives: A 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.

Methods: The 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.

Results: Of 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.

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Conflict of interest statement

Neither honoraria nor any other form of compensation was provided for authorship. Financial arrangements, within the past year, of the authors with companies whose products may be related to the present manuscript are listed, as declared by the authors. M.F. Brin: employee of AbbVie and receives salary and stock/stock options as compensation. R.S. Kirby: received grant funding from the Centers for Disease Control and Prevention, Florida Department of Health, and Maternal and Child Health Bureau/Health Resources and Services Administration; employee of University of South Florida. A. Slavotinek: none reported as relevant to this publication. A.M. Adams: employee of AbbVie and receives salary and stock/stock options as compensation. L. Parker: employee of AbbVie and receives salary as compensation. A. Ukah: employee of AbbVie and receives salary and stock/stock options as compensation. L. Radulian: employee of AbbVie and receives salary and stock/stock options as compensation and is a PhD student at the University of Medicine and Pharmacy. M.R.P. Elmore: employee of AbbVie and receives salary and stock/stock options as compensation. L. Yedigarova: former employee of AbbVie. I. Yushmanova: employee of AbbVie and receives salary and stock/stock options as compensation. M.F. Brin and L. Parker had full access to all the data in the analysis and take responsibility for the integrity of the data and the accuracy of the data analysis. Go to Neurology.org/N for full disclosures.

Figures

Figure
Figure. Distribution of Pregnancies
aPregnancies in which onabotulinumtoxinA injection occurred >3 months before the estimated date of conception were considered ineligible.
See this image and copyright information in PMC

Comment in

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