Pregnancy outcomes following exposure to onabotulinumtoxinA

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. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

Pregnancy outcomes following botulinum toxin type A exposure: A systematic review

“…We were only able to retrieve case series and case reports, but no controlled epidemiological studies have been found. Nineteen studies are included in this review; 11 studies (1 case series [7], 1 survey [8] and 8 case reports [9][10][11][12][13][14][15][16][17]) for the therapeutic BTX-A (onabotulinumtoxinA) exposure during pregnancy included a total of 259 exposed women and 269 infants were with a known outcome (Table 1) and 8 studies (1 case series [18] and 7 case reports [19][20][21][22][23][24][25]) reporting botulism during pregnancy, included a total of 10 women (10 infants) [ Table 2]. a .Single case with four separate singleton pregnancies has been reported.…”

“…‡ The child has been followed for 6.5 years without any neuromuscular or developmental concerns benign brain tumor identified at 13 months]. The previously identified malformations presented no distinct pattern [7]. The observed prevalence rates of spontaneous abortion and elective termination of pregnancy in the prospective part of this study were 15.1% (21/139; 95% CI, 9.4-23.1%) and 5.8% (8/139; 95% CI, 2.5-11.3%).…”

“…However, in the retrospective part, the rates of fetal loss (34.7%) and elective termination rates (14.7%) were much higher than the background rates [9]. Brin et al [7] mentioned that in the total cases with known ages, indication, time of fetal exposure and dose of BTX-A; nearly half of them 70/146 (47.9%) were of advanced age (≥35 years), and 96/190 (50.5%) used for cosmetic purposes, most 166/201 (82.6%)of fetal exposure occurred during the first trimester and the majority 55/137(40.1%) received (<50U) of onabotulinumtoxinA [ Table 1 ].…”

“…The database includes prospective (pregnancies recorded before the outcome was known) or retrospective (pregnancies recorded after the outcome was known) cases. Among 574 reported cases, 232 eligible women (237 infants) with known outcome have been included in Brin et al[7] study. In the prospective part; 137 pregnancies (139 fetuses) ended with 110 live births (79.1%), four of which presented with abnormal outcomes; three birth defects [1 major fetal defect; ventricular septal defect, 2 minor fetal malformations; metatarsus adductus and innocent cardiac murmur] and one birth complication [Horner syndrome] .…”

OnabotulinumtoxinA for chronic migraine during pregnancy: a real world experience on 45 patients

“…Such findings have not been confirmed in humans. A 24-year retrospective study of the Allergan global safety database reviewed 574 onabotulinumtoxinA treatments in pregnancy [ 18 ]. Overall the prevalence of fetal defects was comparable in both the toxin treated and general populations.…”