The Food and Drug Administration has approved an additional warning in labeling for Kybella (deoxycholic acid) injection regarding adverse reactions associated with use of the drug outside of the submental fat region (fat under the chin, known as a “double chin”) and recommends against this unapproved use. The agency approved this revised labeling after its review of FDA Adverse Event Reporting System (FAERS) reports (now known as the FDA Adverse Event Monitoring System) and the medical literature. In this review, FDA determined that when Kybella is administered outside the submental fat region, neuromuscular and other serious adverse events may occur.