FDA Warns of Serious Risks Tied to Misuse of Double-Chin Fat Dissolver

Unapproved use of deoxycholic acid injection (Kybella) outside of the submental fat region may carry a risk of neuromuscular and other potentially serious adverse events, according to an FDA labeling update.

A review of the FDA Adverse Event Reporting System (FAERS) revealed 129 cases of adverse events associated with use of deoxycholic acid in unapproved areas since the product was approved in 2015, the agency stated in a safety communication. The reports included some serious adverse events, such as blurred or reduced vision with periorbital use of deoxycholic acid injection and muscle or nerve injury, including facial paresis and paresthesia.

In announcing deoxycholic acid injection’s approval, the FDA emphasized, “It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area.”

The FAERS review also identified 117 cases of unresolved injection-site nodules or masses that had been present for an average of 143 days at the time of reporting. Nodules and masses occurred after an initial injection or after subsequent injections of deoxycholic acid. Persistent nodules and masses might require medical intervention, the FDA advised.

At the time of approval, the FDA noted that the most common side effects associated with deoxycholic acid injection were swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area. However, in clinical trials, some patients developed nerve injury in the jaw that caused facial muscle weakness, asymmetrical facial expressions, and trouble swallowing following injection of deoxycholic acid.

In a safety communication issued in 2023, the FDA warned against use of unapproved fat-dissolving substances sold online with promises to “reduce fat deposits in areas of the body such as the chin, back, thighs, upper arms, and stomach.” The communication highlighted reports of painful knots, permanent scars, and serious infections following use of unapproved injectable fat dissolvers.