ADVERSE REACTIONS
In two double-blind, placebo-controlled trials, 1516 patients were treated with Denavir (penciclovir cream) and 1541 with placebo. The most frequently reported adverse event was headache, which occurred in 5.3% of the patients treated with Denavir and 5.8% of the placebo-treated patients. The rates of reported local adverse reactions are shown in Table 2 below. One or more local adverse reactions were reported by 2.7% of the patients treated with Denavir and 3.9% of placebotreated patients.
Table 2--Local Adverse Reactions Reported in Phase III Trials
| Penciclovir
n=1516
% | Placebo
n=1541
% |
| Application site reaction | 1.3 | 1.8 |
| Hypesthesia/Local anesthesia | 0.9 | 1.4 |
| Taste pervesion | 0.2 | 0.3 |
| Puritus | 0 | 0.3 |
| Pain | 0 | 0.1 |
| Rash (erthematous) | 0.1 | 0.1 |
| Allergic reaction | 0 | 0.1 |
Two studies, enrolling 108 healthy subjects, were conducted to evaluate the dermal tolerance of 5% penciclovir cream (a 5-fold higher concentration than the commercial formulation) compared to vehicle using repeated occluded patch testing methodology. The 5% penciclovir cream induced mild erythema in approximately one-half of the subjects exposed, an irritancy profile similar to the vehicle control in terms of severity and proportion of subjects with a response. No evidence of sensitization was observed.
Post-Marketing Experience
The following events have been identified from worldwide post-marketing use of Denavir in treatment of recurrent herpes labialis (cold sores) in adults. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Denavir cream.
General: Headache, oral/pharyngeal edema, parosmia.
Skin: Application site reactions, aggravated condition, decreased therapeutic response, erythematous rash, local edema, pain, paresthesia, pruritus, skin discoloration and urticaria.
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