From the FDA Drug Label
5 WARNINGS AND PRECAUTIONS 5.1 Marginal mandibular nerve injury 5.2 Dysphagia 5.3 Injection site hematoma/bruising 5.4 Risk of injecting in proximity to vulnerable anatomic structures 5.5 Injection site alopecia 5.6 Injection site ulceration, necrosis, and infection 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience
The risks of using Gyareum injection (deoxycholic acid) for lipolysis include:
- Marginal mandibular nerve injury
- Dysphagia
- Injection site hematoma/bruising
- Risk of injecting in proximity to vulnerable anatomic structures
- Injection site alopecia
- Injection site ulceration, necrosis, and infection The benefits of using Gyareum injection for lipolysis are not explicitly stated in the provided drug label, but the indication for the drug is implied to be for the reduction of fat in specific areas. 1
From the Research
Gyareum injection is not a recognized or approved medical treatment for lipolysis, and its use poses significant risks to patients without any proven benefits. The risks of using unregulated or unapproved injections for lipolysis can be significant, including infection, inflammation, tissue damage, scarring, uneven fat reduction, and potentially serious systemic reactions 2, 3. For safe and effective fat reduction, patients should instead consider FDA-approved treatments such as deoxycholic acid (Kybella) for submental fat, or other proven options like cryolipolysis (CoolSculpting), laser lipolysis, or traditional liposuction performed by qualified medical professionals 4, 5. These established treatments have known safety profiles and documented efficacy.
Key Considerations
- The use of unknown or unregulated substances like "Gyareum" puts patients at unnecessary risk without any proven benefit 6.
- Always consult with a board-certified dermatologist or plastic surgeon to discuss evidence-based options for body contouring and fat reduction.
- FDA-approved treatments for fat reduction have undergone rigorous testing and have demonstrated safety and efficacy in clinical trials 3.
- The most recent and highest quality study on lipolysis, published in 2020, highlights the importance of using approved treatments and being aware of potential adverse effects 3.
Recommendations
- Patients seeking fat reduction should prioritize FDA-approved treatments over unregulated or unapproved options.
- Consult with a qualified medical professional to determine the best course of treatment for individual needs and goals.
- Be cautious of any treatment that lacks scientific evidence or FDA approval, as it may pose significant risks to patient safety.