KYBELLA SIDE EFFECTS
- Generic Name: deoxycholic acid injection
- Brand Name: Kybella
- Drug Class: Aesthetic Surgery Products
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In two double-blind, placebo-controlled clinical trials 513 subjects were treated with KYBELLA® injection and 506 subjects were treated with placebo. The population was 19-65 years old, 85% were women, 87% Caucasian, 8% African American. At baseline the population had a mean BMI of 29 kg/m2, moderate to severe submental convexity (graded as 2 or 3 on a 0 to 4 scale) and without excessive skin laxity. Subjects received up to 6 treatments at least 1 month apart and were followed for up to 6 months after the last received treatment.
The most commonly reported adverse reactions are listed below (Table 1).
Table 1. Adverse Reactions in the Pooled Trials 1 and 2a
|Injection site reactions||492 (96%)||411 (81%)|
|edema/swelling||448 (87%)||218 (43%)|
|hematoma/bruising||368 (72%)||353 (70%)|
|pain||356 (70%)||160 (32%)|
|numbness||341 (66%)||29 (6%)|
|erythema||136 (27%)||91 (18%)|
|induration||120 (23%)||13 (3%)|
|paresthesia||70 (14%)||20 (4%)|
|nodule||68 (13%)||14 (3%)|
|pruritus||64 (12%)||30 (6%)|
|skin tightness||24 (5%)||6 (1%)|
|site warmth||22 (4%)||8 (2%)|
|nerve injury b||20 (4 %)||1 (<1%)|
|Headache||41 (8%)||20 (4%)|
|Oropharyngeal pain||15 (3%)||7 (1%)|
|Hypertension||13 (3%)||7 (1%)|
|Nausea||12 (2%)||3 (1%)|
|Dysphagia||10 (2%)||1 (<1%)|
|a Adverse reactions that occurred in ≥ 2% KYBELLA® treated subjects and at greater incidence than placebo
b Marginal mandibular nerve paresis
Other adverse reactions associated with the use of KYBELLA® include: injection site hemorrhage, injection site discoloration, pre-syncope/syncope, lymphadenopathy, injection site urticaria, and neck pain.
Adverse reactions that lasted more than 30 days and occurred in more than 10% of subjects were injection site numbness (42%), injection site edema/swelling (20%), injection site pain (16%), and injection site induration (13%).
The following adverse reactions have been identified during post-approval use of KYBELLA®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to KYBELLA® exposure.
Administration site conditions: injection site ulceration, necrosis, alopecia, and scarring.
Immune System Disorders: Hypersensitivity reactions including rash, urticaria, and itching.
Nervous System Disorders: Oral hypoaesthesia and oral paraesthesia.
Procedural Complications: Vascular injury due to inadvertent intravascular injection.
SRC: NLM .