FDA Issues Warning on Kybella Off-Label Injections and Persistent Nodules
The U.S. Food and Drug Administration (FDA) has updated the labeling for Kybella (deoxycholic acid) injection, adding new warnings regarding serious adverse events associated with its use outside the approved submental fat region (under the chin). This action follows a review of reports from the FDA Adverse Event Monitoring System and medical literature. The FDA identified 129 cases of adverse events linked to off-label injections, including visual disturbances, muscle or nerve injury, facial paresis, and paresthesia. Additionally, 117 cases of unresolved injection-site nodules or masses were reported, some persisting for months and requiring medical intervention. Kybella was initially approved in 2015 for improving the appearance of moderate-to-severe fullness under the chin and is not approved for treating subcutaneous fat elsewhere in the body. The updated labeling reinforces the recommendation against off-label use and highlights the potential for persistent nodules and masses, which can occur even wit...
