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Cutivate (Fluticasone Propionate Topical) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

In controlled clinical trials of twice-daily administration, the total incidence of adverse reactions associated with the use of CUTIVATE® Cream was approximately 4%. These adverse reactions were usually mild; self-limiting; and consisted primarily of pruritus, dryness, numbness of fingers, and burning. These events occurred in 2.9%, 1.2%, 1.0%, and 0.6% of patients, respectively.

Two clinical studies compared once- to twice-daily administration of CUTIVATE® Cream for the treatment of moderate to severe eczema. The local drug-related adverse events for the 491 patients enrolled in both studies are shown in Table 1. In the study enrolling both adult and pediatric patients, the incidence of local adverse events in the 119 pediatric patients ages 1 to 12 years was comparable to the 140 patients ages 13 to 62 years.

Fifty-one pediatric patients ages 3 months to 5 years, with moderate to severe eczema, were enrolled in an open-label HPA axis safety study. CUTIVATE® Cream was applied twice daily for 3 to 4 weeks over an arithmetic mean body surface area of 64% (range, 35% to 95%). The mean morning cortisol levels with standard deviations before treatment (prestimulation mean value = 13.76 ± 6.94 mcg/dL, poststimulation mean value = 30.53 ± 7.23 mcg/dL) and at end treatment (prestimulation mean value = 12.32 ± 6.92 mcg/dL, poststimulation mean value = 28.84 ± 7.16 mcg/dL) showed little change. In 2 of 43 (4.7%) patients with end-treatment results, peak cortisol levels following cosyntropin stimulation testing were ≤18 μg/dL, indicating adrenal suppression. Follow-up testing after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally responsive HPA axis. Local drug-related adverse events were transient burning, resolving the same day it was reported; transient urticaria, resolving the same day it was reported; erythematous rash; dusky erythema, resolving within 1 month after cessation of CUTIVATE® Cream; and telangiectasia, resolving within 3 months after stopping CUTIVATE® Cream.

Table 1. Drug-Related Adverse Events—Skin
Adverse Events Fluticasone
Once Daily
(n = 210)
Fluticasone
Twice Daily
(n = 203)
Vehicle
Twice Daily
(n = 78)
Skin infection 1 (0.5%) 0 0
Infected eczema 1 (0.5%) 2 (1.0%) 0
Viral warts 0 1 (0.5%) 0
Herpes simplex 0 1 (0.5%) 0
Impetigo 1 (0.5%) 0 0
Atopic dermatitis 1 (0.5%) 0 0
Eczema 1 (0.5%) 0 0
Exacerbation of 4 (1.9%) 1 (0.5%) 1 (1.3%)
eczema
Erythema 0 2 (1.0%) 0
Burning 2 (1.0%) 2 (1.0%) 2 (2.6%)
Stinging 0 2 (1.0%) 1 (1.3%)
Skin irritation 6 (2.9%) 2 (1.0%) 0
Pruritus 2 (1.0%) 4 (1.9%) 4 (5.1%)
Exacerbation of
pruritus 4 (1.9%) 1 (0.5%) 1 (1.3%)
Folliculitis 1 (0.5%) 1 (0.5%) 0
Blisters 0 1 (0.5%) 0
Dryness of skin 3 (1.4%) 1 (0.5%) 0
Table 2. Adverse Events* From Pediatric Open-Label Trial (n = 51)

*See text for additional detail.

n = 41.

Adverse Events Fluticasone Twice Daily
Burning 1 (2.0%)
Dusky erythema 1 (2.0%)
Erythematous rash 1 (2.0%)
Facial telangiectasia 2 (4.9%)
Non-facial telangiectasia 1 (2.0%)
Urticaria 1 (2.0%)

The following local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreas ing order of occurrence: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, hypertrichosis and miliaria. Also, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroid products.



REPORTS OF SUSPECTED CUTIVATE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Cutivate. The information is not vetted and should not be considered as verified clinical evidence.

Possible Cutivate side effects / adverse reactions in 43 year old female

Reported by a physician from Russian Federation on 2012-06-14

Patient: 43 year old female

Reactions: Burning Sensation, Application Site Erosion, Blister

Adverse event resulted in: hospitalization

Suspect drug(s):
Ketoprofen
    Administration route: Topical
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-19
    End date: 2012-05-20

Cutivate
    Administration route: Topical
    Indication: Dermatitis Allergic
    Start date: 2012-05-21
    End date: 2012-05-21



See index of all Cutivate side effect reports >>

Drug label data at the top of this Page last updated: 2013-06-25

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