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
Hauptverfasser: Brin, Mitchell F., Kirby, Russell S., Slavotinek, Anne, Miller-Messana, Mary Ann, Parker, Lori, Yushmanova, Irina, Yang, Huiying
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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
ISSN:1053-8569
1099-1557
DOI:10.1002/pds.3920