The FDA has updated the prescription labeling for Kybella (deoxycholic acid) to include new warnings regarding serious risks from off-label use and persistent injection-site reactions.
Summary of Key Updates
- Off-Label Injection Risks: Kybella is only approved to treat submental fat (double chin). Following 129 reported adverse cases, the FDA added warnings that off-label injections outside this region can cause severe neuromuscular damage—such as nerve/muscle injury, facial paresis, and paresthesia—as well as vision loss when used near the eyes.
- Persistent Nodules and Masses: Based on 117 reported cases, the updated label warns that Kybella can cause long-lasting injection-site nodules (< 3 cm) and masses (> 3 cm). These tissue growths can occur whether injected inside or outside the chin area, often linger for months, and may require medical intervention to resolve.
- Clinical Guidance: Healthcare providers must review the updated prescribing information before administration and instruct patients to seek immediate medical care if they display signs of nerve paresis, swallowing difficulties, or severe injection-site reactions.
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