FDA Warns of Serious Reactions with Kybella for Submental Fat
核心洞察
The FDA approved updated Kybella labeling warning that deoxycholic acid injection may cause neuromuscular and other serious adverse events when used outside the submental fat region.
The agency added a warning for injection-site nodules and masses that may not resolve and may require medical intervention, occurring in or outside the submental area.
The review identified 129 adverse event cases from unapproved use, including blurred or reduced vision and facial paresis (搜索) or paresthesia (搜索), plus 117 unresolved nodule and mass cases.
The FDA has approved updated labeling for Kybella (deoxycholic acid; Allergan Aesthetics (搜索), an AbbVie company) adding a warning that the injection may cause neuromuscular and other serious adverse events when administered outside the submental fat region, according to a drug safety communication. The agency also approved a warning for serious injection-site nodules and masses that may not resolve over time and may require medical intervention, which can occur with injections in or outside the submental fat region.
The decision followed an FDA review of reports from the FDA Adverse Event Reporting System, now the FDA Adverse Event Monitoring System, and evidence from medical literature. The agency identified 129 cases of adverse events linked to Kybella injections outside the submental fat region since approval, including blurred or reduced vision with periorbital use and muscle or nerve injury such as facial paresis (搜索) and paresthesia (搜索). It also found 117 cases of unresolved nodules, defined as growths 3 cm or smaller, and masses, defined as growths larger than 3 cm; these had been present for an average of approximately 5 months and followed an initial or subsequent injection.
Kybella was approved in 2015 for improvement in the appearance of moderate to severe fullness associated with submental fat in adults. Patients can receive up to six injections per treatment, to a maximum of 50 injections given at least 1 month apart, and the product is not approved for subcutaneous fat outside the submental region. The FDA instructed healthcare workers to review the prescribing information before injecting Kybella and to advise patients to seek medical attention for signs of marginal mandibular nerve paresis (搜索), difficulty swallowing or serious injection site reactions.