Is OnabotulinumtoxinA Safe in Pregnancy?

Analysis of 29 years of postmarketing data provides further reassurance on exposures in early pregnancy.

To examine the long-term safety of onabotulinumtoxinA use preconception and following pregnancy, researchers conducted a manufacturer-sponsored study including patients treated with onabotulinumtoxinA during pregnancy or ≤3 months prior to conception during a 29-year period. Participants were identified via postmarketing surveillance using the Allergan Global Safety Database. Data for birth defects of any live births during this time period were included.

Among 913 pregnancies identified, 397 (44%) had known outcomes. The most common indications for onabotulinumtoxinA in this cohort were aesthetic (35%) and migraine or headache (30%). In 318 of these pregnancies, 94.6% of onabotulinumtoxinA exposure occurred within 3 months before conception…

Reviewing Author

Michael S. Okun, MD

Disclosures

Consultant/Advisory BoardParkinson’s Foundation; Tourette Association of America

Speaker’s BureauMedscape/WebMD CME, Movement Disorders Society CME, American Academy of Neurology CME

RoyaltiesBooks4Patients; Demos; Cambridge; Taylor and Francis; Robert Rose; Public Affairs

Grant/Research SupportNational Institutes of Health; Parkinson’s Foundation; Tourette Association of America; University of Florida Foundation

Editorial BoardsTremor and Other Hyperkinetic Movements; JAMA Neurology

Leadership Positions in Professional SocietiesParkinson’s Foundation (Medical Advisor)