ADVERSE REACTIONS
Controlled Clinical Trials
Systemic Adverse Effects: In controlled clinical trials of patients treated with PRUDOXIN Cream, the most common systemic adverse event reported was drowsiness. Drowsiness occurred in 71 of 330 (22%) of patients treated with PRUDOXIN Cream compared to 7 of 334 (2%) of patients treated with vehicle cream. Drowsiness resulted in the premature discontinuation of the drug in approximately 5% of patients treated with PRUDOXIN Cream in controlled clinical trials.
Local Site Adverse Effects: In controlled clinical trials of patients treated with PRUDOXIN Cream, the most common local site adverse event reported was burning and/or stinging at the site of application. These occurred in 76 of 330 (23%) of patients treated with PRUDOXIN Cream compared to 54 of 334 (16%) of patients treated with vehicle cream. Most of these reactions were categorized as "mild"; however, approximately 25% of patients who reported burning and/or stinging reported the reaction as "severe". Four patients treated with PRUDOXIN Cream withdrew from the study because of the burning and/or stinging.
The table below presents the adverse events reported at an incidence of ≥ 1 % in either PRUDOXIN or vehicle cream treatment groups during the trials:
| Adverse Event |
PRUDOXIN
N=330 |
Vehicle
N=334 |
|
1Includes reports of “dry lips”, “dry throat”, and “thirst” |
|
2Includes reports of “pruritus exacerbated” |
|
3Includes report of “increased irritation at application site” |
|
4Includes reports of “lightheadedness” and “dizziness/vertigo” |
|
5Includes reports of “bitter taste” and “metallic taste in mouth” |
| Burning /Stinging |
76 (23.0%) |
54 (16.2%) |
| Drowsiness |
71 (21.5%) |
7 (2.1%) |
| Dry Mouth1
|
32 (9.7%) |
4 (1.2%) |
| Pruritus2
|
13 (3.9%) |
20 (6.0%) |
| Fatigue/Tiredness |
10 (3.0%) |
5 (1.5%) |
| Exacerbated Eczema |
10 (3.0%) |
8 (2.4%) |
| Other Application Site Reaction3
|
10 (3.0%) |
16 (4.8%) |
| Dizziness4
|
7 (2.1%) |
3 (0.9%) |
| Mental/Emotional Changes |
6 (1.8%) |
1 (0.3%) |
| Taste Perversion5
|
5 (1.5%) |
1 (0.3%) |
| Edema |
4 (1.2%) |
1 (0.3%) |
| Headache |
3 (0.9%) |
14 (4.2%) |
Adverse events occurring in 0.5% to < 1.0% of PRUDOXIN Cream treated patients in the controlled clinical trials included: nervousness/anxiety, tongue numbness, fever, and nausea.
Post Marketing Experience
Twenty-six cases of allergic contact dermatitis have been reported in patients using PRUDOXIN Cream, twenty of which were documented by positive patch test to doxepin 5% cream.
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