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FDA Strengthens Kybella Warning Over Adverse Events
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In Short: The FDA is reinforcing warnings about adverse events linked to deoxycholic acid injections, commonly known as Kybella.
The FDA has issued a new warning about adverse events associated with deoxycholic acid injections, commonly known as Kybella, citing newly identified risks.
In a drug safety communication, the agency highlighted adverse events such as injection site nodules and masses, which may or may not resolve over time, and noted that these issues have been identified with both approved and unapproved uses.
The FDA's review of its Adverse Event Monitoring System and medical literature revealed 129 cases of adverse events when deoxycholic acid was used outside the chin area, including blurred vision when injected around the eyes and facial paresis and paresthesia.
According to Kybella's FDA-approved label, the formation of nodules was observed in clinical trials, affecting approximately 13% of patients.
A 2024 paper in Aesthetic Surgery Journal Open Forum detailed 'avoidable, uncommon, and serious adverse events' reported in real-world settings, suggesting that proactive measures could prevent such incidents.
Kybella, manufactured by Allergan Aesthetics (an AbbVie company), was approved in 2015 to improve the appearance of submental fat but is also used off-label in other body areas.
The label update now explicitly states that some nodules and masses may not resolve and may require medical intervention, reiterating that Kybella should not be used outside the submental area.
Post-marketing reports in the literature have documented injuries and adverse events associated with deoxycholic acid injections, and during the 2015 FDA advisory committee meeting, officials expressed concern about marginal mandibular nerve injury, which affected 4% of those receiving the injections compared to 1% of those receiving placebo.
What this adds
The FDA's updated label now includes a stronger warning about the potential for unresolved nodules and masses, emphasizing the need for caution when using Kybella.
What's still developing
- Nothing material beyond the confirmed record.
Sources
- Medscapelink