FDA Approves Additional Warning for Kybella Labeling
The FDA has approved updated labeling for Kybella (deoxycholic acid) injection, adding new warnings about serious adverse events associated with use of the drug outside of the submental fat region and highlighting risks of persistent injection-site nodules and masses.
Kybella is approved for improving the appearance of moderate-to-severe fullness associated with submental fat in adults and is not approved for the treatment of fat deposits elsewhere on the body.
The FDA said it reviewed reports submitted to the FDA Adverse Event Reporting System (FAERS) and published medical literature before determining that administration of Kybella outside the submental area may result in neuromuscular and other serious adverse events. Reported complications include blurred or reduced vision, involuntary eye contractions, muscle and nerve damage, weakness, numbness and difficulty walking.
The agency also approved new language in the Warnings and Precautions section regarding injection-site nodules and masses. According to the FDA, reports reviewed by the agency found an association between deoxycholic acid injections and nodules measuring 3 centimeters or smaller, as well as larger masses that may not resolve over time and may require medical intervention. The FDA said these reactions have been reported both when the drug is used as indicated under the chin and when it is administered outside the approved treatment area.
The updated labeling adds to existing warnings associated with Kybella treatment, including nerve injury around the lower lip, tongue and jaw; difficulty swallowing; bruising; tissue damage; vascular injury; infection; ulceration; necrosis; and injection-site hair loss.
The FDA noted that Kybella and generic deoxycholic acid injection products are the only FDA-approved drugs for improving the appearance of moderate-to-severe fullness associated with submental fat and urged consumers not to use unapproved injection lipolysis (fat-dissolving) products.
