Olux (Clobetasol Propionate Topical) - Side Effects and Adverse Reactions

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

Dermatosis	OLUX Foam
Psoriasis	1 of 9
Atopic Dermatatitis 1	4 of 4

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.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO OLUX

Possible Olux side effects / adverse reactions in 7 year old female

Reported by a physician from United States on 2007-01-25

Patient: 7 year old female weighing 21.8 kg (47.9 pounds)

Reactions: Blood Cortisol Decreased, Growth Retardation, Adrenal Neoplasm

Suspect drug(s):
Luxiq
    Dosage: 0.12 pct; top
    Administration route: Topical
    Indication: Alopecia Totalis
    Start date: 2005-08-08
    End date: 2006-08-01

Olux
    Dosage: 0.05 pct; biw; top
    Administration route: Topical
    Indication: Alopecia Totalis
    Start date: 2005-08-08
    End date: 2006-08-01

Kenalog
    Dosage: 15 mg; qm;
    Indication: Alopecia Totalis

Possible Olux side effects / adverse reactions in 7 year old female

Reported by a physician from United States on 2007-04-05

Patient: 7 year old female weighing 21.8 kg (47.9 pounds)

Reactions: Blood Cortisol Decreased, Growth Retardation

Suspect drug(s):
Luxiq
    Dosage: 0.12 pct; ;top
    Administration route: Topical
    Indication: Alopecia Totalis
    Start date: 2005-08-08
    End date: 2006-08-01

Olux
    Dosage: 0.05 pct;biw;top
    Administration route: Topical
    Indication: Alopecia Totalis
    Start date: 2005-08-08
    End date: 2006-08-01

Kenalog
    Dosage: 15 mg;qm;
    Indication: Alopecia Totalis

Possible Olux side effects / adverse reactions in 2 year old male

Reported by a physician from United States on 2007-07-06

Patient: 2 year old male

Reactions: Vomiting, Accidental Exposure

Suspect drug(s):
Olux