10/16/2026
π¨ The FDA has added a new warning to Kybellaβs label for injections outside the approved chin area.
In September, the FDA updated Kybellaβs labeling and issued a Drug Safety Communication after reviewing adverse event reports and medical literature going back to the drugβs 2015 approval. Kybella is still approved for fat under the chin. But the label now states that using it outside that area is not approved and not recommended.
What was reported:
β 129 cases involving injections outside the chin area, including blurred or reduced vision after injections around the eyes, muscle or nerve injury such as facial weakness, and abnormal sensation
β 117 cases of nodules or masses that didnβt resolve, lasting about five months on average. These include injections both inside and outside the chin area, and some may need medical intervention.
Reports donβt confirm cause, but the label now carries clearer instructions. Providers should counsel patients on signs of nerve injury, difficulty swallowing, and serious injection-site reactions. Treatment should stop if a patient develops ulceration, necrosis, a nodule, a mass, or infection.
Off-label use isnβt illegal. But βnot recommendedβ is now in writing, and if a patient has a reaction, the updated label is the first document anyone will check.
What to do now:
β Review your Kybella protocols against the updated label
β Update consent forms to reflect the new warnings
β Brief injectors on when to stop treatment
β Follow up on any nodule or mass
β Report suspected reactions through MedWatch
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