PURPOSE: The purpose of the present study was to determine the most commonly reported complications with cosmetic botulinum toxin type A (BTX-A) treatments.
MATERIALS AND METHODS: The present study was a cross-sectional review of the US Food and Drug Administration (FDA) Adverse Event Reporting System. From January 2014 through September 2019, the records were included in the study sample if they implicated Botox (onabotulinumtoxinA), Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), or Jeuveau (prabotulinumtoxinA-xvfs), and if the indication for use had been to perform a cosmetic skin procedure. The study predictors included patient (ie, age, weight, gender) and treatment (ie, product, country of treatment, 10 most common reactions) characteristics. The study outcome was the frequency of serious events as defined by the standard FDA definition for biologic products. A multivariate logistical regression model was created for the study outcome using all significant univariate predictors.
RESULTS: The final sample included 10,577 reports detailing 29,471 adverse events and covering 1,473 reactions. The mean patient age was 48.4 +/- 11.2 years, and nearly all patients were women (95.0%). The most commonly reported events were pain (9.3%), swelling (6.4%), and eyelid/brow ptosis (6.1%). Serious outcomes had occurred in 13.5% of patients. In the multivariate model, serious outcomes were independently associated with older age, heavier weight, headache, allergy, vision changes, fatigue, facial paresis, and dizziness but not with pain, swelling, or ptosis.
CONCLUSIONS: A wide range of alleged complications have been reported to the FDA, many of which were likely not mediated through injection or direct toxin effects. Patients might have inaccurately attributed some of their symptoms to BTX-A, and providers should be prepared to dispel any misinformation. Local complications such as pain, swelling, and ptosis were the most common but were not associated with serious patient outcomes. However, constitutional symptoms should be approached more carefully.
|組織名||Resident, Division of Oral and Maxillofacial Surgery,;NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY.;Electronic address: firstname.lastname@example.org.;Dental Student, Division of Oral and Maxillofacial Surgery,;Program Director, Division of Oral and Maxillofacial Surgery,|