Pregnancy outcomes following exposure to onabotulinumtoxinA
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, i...
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Veröffentlicht in: | Pharmacoepidemiology and drug safety 2016-02, Vol.25 (2), p.179-187 |
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Sprache: | eng |
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Zusammenfassung: | 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 |
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ISSN: | 1053-8569 1099-1557 |
DOI: | 10.1002/pds.3920 |