Drug updated on 12/11/2024
Dosage Form | Injection (subcutaneous; 10 mg/mL) |
Drug Class | Cytolytic drugs |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
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Summary
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Submental Fat Reduction: Phase 3 randomized control trials and a systematic review demonstrated that deoxycholic acid significantly reduced submental fat compared to placebo, with no differences in efficacy between doses of 1 mg/cm² and 2 mg/cm².
- General Safety Profile: Common mild to moderate adverse effects associated with deoxycholic acid included injection site reactions, such as pain, erythema, numbness, swelling, and pruritus, most of which were transient and resolved within the treatment interval. Rare but severe adverse events, including severe pain, dysphagia, and gastrointestinal upset, were noted, particularly in cases involving higher injection volumes.
- Procedure-Related Serious Adverse Events (SAEs): Serious adverse events, primarily due to procedural factors, were reported in real-world settings, highlighting the need for careful administration to mitigate avoidable risks.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Kybella (deoxycholic acid) Prescribing Information. | 2023 | AbbVie Inc., North Chicago, IL |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Management of Serious Adverse Events Following Deoxycholic Acid Injection for Submental and Jowl Fat Reduction: A Systematic Review and Management Recommendations | 2024 | Aesthetic Surgery Journal |
Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction ‒ A systematic review and meta-analysis of randomized clinical trials | 2023 | Clinics (Sao Paulo, Brazil) |
Bile acid metabolites in early pregnancy and risk of gestational diabetes mellitus: Results from a prospective cohort study | 2023 | Diabetes, Obesity & Metabolism |
Efficacy and safety of injectable deoxycholic acid for submental fat reduction: a systematic review and meta-analysis of randomized controlled trials | 2021 | Expert Review of Clinical Pharmacology |
Adverse Events of Injectable Deoxycholic Acid | 2020 | Dermatologic Surgery |