KYBELLA SIDE EFFECTS
- Generic Name: deoxycholic acid injection
- Brand Name: Kybella
- Drug Class: Aesthetic Surgery Products
SIDE EFFECTS
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
| Adverse reactions | KYBELLA® (N=513) n (%) |
Placebo (N=506) n (%) |
| 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 |
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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%).
Postmarketing Experience
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 .