ADVERSE REACTIONS
While clinical studies conducted with ACZONE™ Gel, 5%, for acne vulgaris did not demonstrate evidence of clinically significant anemia, an increased reticulocyte count and a decreased hemoglobin level were found in a G6PD deficient patient who had a complete blood count performed. Only 25 patients with low plasma glucose 6-phosphate dehydrogenase activity treated with ACZONE™ Gel, 5%, were included in the clinical study program.
Serious adverse events reported in patients treated with ACZONE™ Gel, 5%, during clinical trials included but were not limited to the following:
Nervous system/Psychiatric – Suicide attempt, tonic clonic movements.
Gastrointestinal – Abdominal pain, severe vomiting, pancreatitis.
Other – Severe pharyngitis
Combined contact sensitization/irritation studies with ACZONE™ Gel, 5%, in 253 healthy subjects resulted in at least 3 subjects with moderate erythema. ACZONE™ Gel, 5%, did not induce phototoxicity or photoallergy in human dermal safety studies.
ACZONE™ Gel, 5%, was evaluated for 12 weeks in four controlled studies for local cutaneous events in 1819 patients. The most common events reported from these studies include oiliness/peeling, dryness, and erythema. These data are shown by severity in Table 3 below.
Table 3 - Application Site Adverse Events by Maximum Severity from Four 12-Week, Vehicle-Controlled Studies | ACZONE™(N=1819) | Vehicle(N=1660) |
|---|
| Application Site Event | Mild | Moderate | Severe | Mild | Moderate | Severe |
| Erythema | 9% | 5% | <1% | 9% | 6% | <1% |
| Dryness | 14% | 3% | <1% | 14% | 4% | <1% |
| Oiliness/Peeling | 13% | 6% | <1% | 15% | 6% | <1% |
There were no significant differences in the adverse event rates between ACZONE™ Gel, 5%, and vehicle control treated patients. The adverse events occurring in at least 1% of patients in either arm in the four vehicle controlled studies are presented in Table 4.
Table 4 - Adverse Events Occurring in at least 1% of Patients in Four Vehicle Controlled Studies | ACZONE™
N=1819 | Vehicle
N=1660 |
| Application Site Reaction NOS | 18% | 20% |
| Application Site Dryness | 16% | 17% |
| Application Site Erythema | 13% | 14% |
| Application Site Burning | 1% | 2% |
| Application Site Pruritus | 1% | 1% |
| Pyrexia | 1% | 1% |
| Nasopharyngitis | 5% | 6% |
| Upper Respiratory Tract Inf. NOS | 3% | 3% |
| Sinusitis NOS | 2% | 1% |
| Influenza | 1% | 1% |
| Pharyngitis | 2% | 2% |
| Cough | 2% | 2% |
| Joint Sprain | 1% | 1% |
| Headache NOS | 4% | 4% |
One patient treated with topical dapsone in the clinical trials had facial swelling which led to discontinuation of medication.
In addition, 486 patients were evaluated in a 12 month safety study. The adverse event profile in this study was consistent with that observed in the vehicle-controlled studies.
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