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    Avoiding Kybella complications

    In April 2015, when the FDA announced it had approved Kybella (deoxycholic acid, Kythera) as a treatment for adults with moderate-to-severe submental fat, the government agency noted that Kybella can cause serious side effects, including skin necrosis and nerve injury.

    “Kybella is a cytolytic drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin,” according to the FDA

    The most common side effects of Kybella include swelling, bruising, pain, numbness, redness and areas of firmness, according to the FDA, but nerve injury in the jaw, resulting in an uneven smile or facial muscle weakness and trouble swallowing, is another potential side effect.

    Researchers assessed Kybella’s safety in two pivotal phase 3 clinical trials, of 1,019 subjects — 513 were randomized to the Kybella arm; the rest were treated with placebo. In the studies, researchers followed participants for 24 weeks after their last treatments and reported these side effects in the active arms: injection site edema/swelling in 87% of those in the studies; injection site hematoma in 72%, and injection site pain in 70%.

    “The vast majority of injection site reactions was described by the investigators as mild to moderate and was considered resolved by the end of the trial,” according to the FDA. “The marginal mandibular nerve injuries in the [Kybella] treatment arm occurred at the 4% rate and dysphagia at 2%. All cases (except one of dysphagia) completely resolved without any treatment.”

    In This Article

    Safety in Question?

    2 Complications to Avoid

    Follow the Rules

    NEXT: Safety in Question?


    Lisette Hilton
    Lisette Hilton, president of Words Come Alive, has written about health care, the science and business of medicine, fitness and wellness ...

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