Unapproved use of deoxycholic acid injection, commonly known as Kybella, outside of the submental fat region may carry significant risks, including neuromuscular complications and other serious adverse events, as highlighted by a recent update from the FDA.
Adverse Events and Reports
A review of the FDA Adverse Event Reporting System (FAERS) revealed 129 cases of adverse events related to the application of deoxycholic acid in unapproved areas since its approval in 2015. The agency shared this information through a safety communication. Reports have included serious issues such as blurred or decreased vision when used around the eyes, as well as muscle or nerve injuries, which may lead to facial paresis and paresthesia.
Approved Usage and Safety Concerns
Upon approval of deoxycholic acid injection, the FDA asserted the importance of its approved usage, which is strictly for treating fat beneath the chin. They emphasized that the safety and efficacy of Kybella in other body areas remain unknown.
The FAERS review also documented 117 cases of unresolved injection-site nodules or masses, which were typically present for an average of 143 days when reported. These nodules or masses may necessitate medical intervention after initial or subsequent injections of deoxycholic acid.
Common Side Effects
Initially, the FDA indicated that the most frequent side effects associated with the injection include swelling, bruising, pain, numbness, redness, and localized hardness in the treatment area. However, clinical trials have shown that some patients experienced nerve damage in the jaw, leading to facial muscle weakness, asymmetrical expressions, and difficulties with swallowing following deoxycholic acid injections.
Warnings Against Unapproved Substances
In a safety communication released in 2023, the FDA cautioned against the usage of unapproved fat-dissolving agents found online promising to
Fuente: https://www.medpagetoday.com/dermatology/generaldermatology/123024
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