ADVERSE REACTIONS
In a controlled pharmacokinetic study, 5 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of Olux Foam therapy to at least 20% of the body surface area. Of the 13 subjects studied, 1 of 9 with psoriasis were suppressed after 14 days and all 4 of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with Olux Foam. (See Table 3 below.)
Table 3: Subjects with reversible HPA axis suppression at any time during treatment
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Dermatosis
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Olux Foam
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Psoriasis
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1 of 9
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Atopic Dermatitis
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4 of 4
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Systemic absorption of topical corticosteroids has produced reversible adrenal suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients (see PRECAUTIONS).
In a controlled clinical trial (188 subjects) with Olux Foam in subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the Olux Foam treated subjects. In two controlled clinical trials (360 subjects) with Olux Foam in subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the Olux Foam treated subjects included application site burning (10%), application site dryness (< 1%), and other application site reactions (4%).
In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).
The following additional local adverse reactions have been reported with topical corticosteroids, but they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids such as Olux Foam. These reactions are listed in an approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, and miliaria.
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REPORTS OF SUSPECTED OLUX SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Olux. The information is not vetted and should not be considered as verified clinical evidence.
Possible Olux side effects / adverse reactions in 28 year old male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: 28 year old male
Reactions: Adverse Event, Erythema
Suspect drug(s):
Olux
Other drugs received by patient: NO Concurrent Medication
Possible Olux side effects / adverse reactions in 74 year old female
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: 74 year old female
Reactions: Expired Drug Administered
Suspect drug(s):
Olux
Other drugs received by patient: Diabetes Medication; Sudafed 12 Hour; Heart Medication; Mucinex
Possible Olux side effects / adverse reactions in 49 year old female
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: 49 year old female
Reactions: Burning Sensation, Hyperaesthesia
Suspect drug(s):
Olux
Other drugs received by patient: Calcium; Dexlansoprazole; Femhrt; CO Q10; Probiotics; Vitamin TAB
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