The FDA has approved additional safety information for Kybella, or deoxycholic acid injection, warning against use outside the approved submental fat area beneath the chin.
The labeling change follows an FDA review of adverse-event reports and medical literature. The agency said it identified serious neuromuscular and other adverse events when deoxycholic acid was injected outside the submental region.
Kybella was approved in 2015 to improve the appearance of moderate-to-severe fullness associated with submental fat in adults. The drug is not approved for treating fat in other body areas. A generic deoxycholic acid injection product is also FDA-approved.
FDA identified 129 cases of adverse events associated with use of deoxycholic acid injection outside the approved submental area since Kybella’s 2015 approval. Reported events included blurred or reduced vision following use around the eye area, as well as muscle or nerve injury, facial paresis and paresthesia.
The revised labeling also adds warnings regarding injection-site nodules and masses. FDA identified 117 cases of unresolved nodules measuring 3 centimeters or less, or masses larger than 3 centimeters, associated with deoxycholic acid injections.
At the time of reporting, the unresolved nodules or masses had been present for a mean of 143 days, or about five months. FDA said the events occurred after either initial or subsequent injections and could occur with use in the approved submental area or elsewhere.
The agency said nodules and masses may not resolve and may require medical intervention.
Kybella is administered by healthcare providers in an injection-lipolysis procedure. Patients may receive up to six treatments at least one month apart, with each treatment consisting of up to 50 subcutaneous injections.
FDA advised patients who experience adverse events after receiving Kybella to seek medical attention.
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