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. 2016 Feb;25(2):179-87.
doi: 10.1002/pds.3920. Epub 2015 Dec 4.

Pregnancy outcomes following exposure to onabotulinumtoxinA

Mitchell F Brin  1   2 , Russell S Kirby  3 , Anne Slavotinek  4 , Mary Ann Miller-Messana  1 , Lori Parker  1 , Irina Yushmanova  1 , Huiying Yang  1   5
Affiliations

Pregnancy outcomes following exposure to onabotulinumtoxinA

Mitchell F Brin et al. Pharmacoepidemiol Drug Saf. 2016 Feb.

Abstract

Purpose: 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.

Keywords: fetal defects; onabotulinumtoxinA; pharmacoepidemiology; pregnancy.

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Figures

Figure 1
Figure 1
Distribution of pregnancy cases. *Pregnancies in which onabotulinumtoxinA injection occurred >3 months before the estimated date of conception
See this image and copyright information in PMC

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