SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, 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 clinical practice.
The safety of ZINGO has been evaluated in 10 clinical trials, five in adults and five in pediatric patients.
The five adult clinical trials consisted of a randomized, double-blind, parallel-arm, sham-placebo controlled Phase 3 trial that enrolled 693 patients, two randomized, double-blind, crossover design, sham-placebo controlled Phase 1 trials that enrolled 455 patients, and two open-label studies that enrolled 44 patients. A total of 742 adults received an active treatment with an active treatment that delivered a 0.5 mg dose of lidocaine, while 775 received placebo.
The five pediatric clinical trials consisted of five randomized, double-blind, parallel-arm, sham-placebo controlled trials in which 1761 patients, ages 3 to 18, received either ZINGO or a sham placebo device. A total of 906 pediatric patients received active treatment, while 855 received placebo.
Application Site Reaction
The application site was specifically assessed for four categories of skin site reaction (erythema, edema, pruritus, and petechiae).
In adults, erythema occurred in 67.3% of ZINGO-treated patients, and in 25.0% of placebo-treated patients. Petechiae occurred in 46.4% of ZINGO-treated patients, and in 7.0% of placebo-treated patients. Edema occurred in 4.3% of ZINGOtreated patients, and in 0.8% of placebo-treated patients. Pruritus occurred in 9.4% of ZINGO-treated patients and in 6.2% of placebo-treated patients.
In pediatric patients, erythema occurred in 53% of ZINGO-treated patients, and in 27% of placebo-treated patients. Petechiae occurred in 44% of ZINGO-treated patients, and in 5% of placebo-treated patients. Edema occurred in 8% of ZINGO-treated patients, and in 3% of placebo-treated patients. Pruritus occurred in 1% of patients in both treatment groups.
Adverse Reactions
Amongst the 742 adult patients receiving active treatment and 775 adult patients receiving sham placebo treatment in the 5 adult studies, the percentage of adult patients with any adverse reactions was 3.9% in the active-treated patients and 4.9% in the sham placebo treated patients.
Most adverse reactions were application-site related (i.e., hypoaesthesia (0% active, 0.5% sham placebo), burning (0.54% active, 0.4% sham placebo), and venipuncture site hemorrhage (0.4% active, 1.7% sham placebo)).
The most common systemic adverse reaction was dizziness, which occurred in 0.9% of active-treated adult patients and in 0.7% of sham placebo treated adult patients. No other systemic adverse events occurred in more than two patients in either treatment group.
Amongst the 906 pediatric patients receiving active treatment and 855 pediatric patients receiving sham placebo treatment, the percentage of pediatric patients with any adverse reactions was approximately 9% in each treatment group.
Most adverse reactions were application-site related (i.e., bruising, burning, pain, contusion, hemorrhage), occurring in 4% of pediatric patients in each treatment group.
The most common systemic adverse reactions were nausea (2%) and vomiting (1%).
SRC: NLM .