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ACZONE (DAPSONE): ADVERSE REACTIONS
Clinical Studies Experience
Because clinical trials are conducted under prescribed 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 practice.
Serious adverse reactions reported in patients treated with Dapsone (Aczone) gel 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
In the clinical trials, a total of 12 out of 4032 patients were reported to have depression (3 of 1660 treated with vehicle and 9 of 2372 treated with Dapsone (Aczone) gel 5%). Psychosis was reported in 2 of 2372 patients treated with Aczone and in 0 of 1660 patients treated with vehicle.
Combined contact sensitization/irritation studies with Aczone gel in 253 healthy subjects resulted in at least 3 subjects with moderate erythema. This medicine 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.
One patient treated with Aczone (Dapsone) gel 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.
Experience with oral use of Dapsone
Although not observed in the clinical trials with Aczone (topical Dapsone) gel 5% serious adverse reactions have been reported with oral use of dapsone, including agranulocytosis, hemolytic anemia, peripheral neuropathy (motor loss and muscle weakness), and skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria).
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