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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 ACZONE Gel (dapsone) , 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

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 ACZONE Gel (dapsone) , 5%). Psychosis was reported in 2 of 2372 patients treated with ACZONE Gel (dapsone) , 5%, and in 0 of 1660 patients treated with vehicle.

Combined contact sensitization/irritation studies with ACZONE Gel (dapsone) , 5%, in 253 healthy subjects resulted in at least 3 subjects with moderate erythema. ACZONE Gel (dapsone) , 5%, did not induce phototoxicity or photoallergy in human dermal safety studies.

ACZONE Gel (dapsone) , 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 1 below.

Table 1: Application Site Adverse Reactions by Maximum Severity

  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%

The adverse reactions occurring in at least 1% of patients in either arm in the four vehicle controlled studies are presented in Table 2.

Table 2 : Adverse Reactions Occurring in at least 1% of Patients

  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%
NOS = Not otherwise specified

One patient treated with ACZONE Gel (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.

Experience with Oral Use of Dapsone

Although not observed in the clinical trials with ACZONE Gel (topical dapsone) 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).