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Abstract
Introduction
This is the first study to evaluate Health Canada’s national reporting database, MedEffect™, to assess the safety and efficacy of esthetic injectables.
Objective
Describe adverse reactions (ARs) associated with soft tissue fillers and neurotoxins.
Methods
Investigators reviewed MedEffect™ for reports associated with esthetic injectables from January 1 1965 to March 31 2018. Descriptive analyses of the reports were completed, including information on reporters’, patients’, and AR characteristics.
Results
A total of 1459 individual reports containing 5714 ARs were evaluated. The majority (n = 5705; 99.84%) of reported ARs were related to neurotoxins and only 0.16% (n = 9) were related to soft tissue fillers. Most reports were submitted by health professionals (n = 4930; 86%), indicated that the product was ineffective (n = 2428; 42.5%) and that the result of ARs were unknown (n = 4835; 84.6%).
Conclusions
ARs associated with the use of neurotoxins and soft tissue fillers are underreported in Canada. More complete and representative information regarding ARs is necessary for the development and validation of treatment algorithms and management strategies.
Disclosure statement
The authors wish to disclose the following facts which may be considered as potential conflicts of interest: Dr. Andreas Nikolis is a consultant speaker and research collaborator for Galderma, Allergan and Merz Pharma. The remaining authors have no conflicts of interest to disclose. This research did not receive any specific funding from the public, commercial or not-for-profit sectors.
Data availability
The dataset analyzed during the current study is available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html.