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FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Use

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.

The agency has also approved language in the Warnings and Precautions section of labeling about the serious risks of injection site nodules and masses. These newly identified risks are being added to information on other injection site reactions already described in labeling. In this same FAERS review, the agency determined that there is an association between deoxycholic acid injection and reports of injection site nodules (3 cm or smaller) or masses (larger than 3 cm), which may not resolve over time and may require medical intervention. Nodules and masses may occur when patients receive deoxycholic acid injections as indicated in the submental fat region and when patients receive injections of the drug outside the submental fat region. 

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