Uncommon Adverse Effects of Deoxycholic Acid Injection for Submental Fullness: Beyond the Clinical Trials
Autor: | Melinda Gooderham, Kristy C Metzger, Dorota Kadlubowska, Erika L Crowley |
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Rok vydání: | 2020 |
Předmět: |
Chin
medicine.medical_specialty Injections Subcutaneous Subcutaneous Fat Phases of clinical research Cosmetic Techniques Dermatology 030207 dermatology & venereal diseases 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Lipectomy Humans Medicine Risks and benefits Adverse effect business.industry Deoxycholic acid Patient counselling Injection Site Reaction Clinical trial chemistry Injection site pain 030220 oncology & carcinogenesis Surgery Dermatologic Agents business Deoxycholic Acid |
Zdroj: | Journal of Cutaneous Medicine and Surgery. 24:619-624 |
ISSN: | 1615-7109 1203-4754 |
DOI: | 10.1177/1203475420943270 |
Popis: | Deoxycholic acid (BELKYRATM, Allergan, Markham, ON, Canada) is a minimally invasive injectable treatment approved by Health Canada for the nonsurgical reduction of submental fullness. Multiple phase III clinical trials have proven the efficacy and safety of deoxycholic acid. In the clinical trials, the most common adverse events (AEs) reported, such as injection site pain, numbness, swelling, bruising and induration, were transient and mild-to-moderate in severity. Additional postmarketing AEs have been reported in the literature. In this study, we reviewed the uncommon reported events and aimed to increase clinician awareness of the potential adverse effects for patient counselling of risks and benefits, identify AEs of procedures that may be performed outside of the medical environment, and identify factors that increase the risk of an adverse event. Beyond the clinical trials, real-world case reports and case series have been reported for the AEs of alopecia, transient neuropraxia, vascular occlusive events/vascular injury, and skin necrosis. Dermatologists need to be aware of these risks, for the treatment and management of their own patients and for those patients who may be treated outside the medical clinic environment that present for medical management of these AEs. |
Databáze: | OpenAIRE |
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