Fluticasone Adverse Reactions
- acneiform rash
- adrenocortical insufficiency
- agitation
- anaphylactoid reactions
- angioedema
- anxiety
- arthralgia
- bronchospasm
- candidiasis
- cataracts
- contact dermatitis
- Cushing’s syndrome
- depression
- diarrhea
- dizziness
- dysmenorrhea
- dyspepsia
- dysphonia
- eosinophilia
- epiphora
- epistaxis
- erythema
- fever
- folliculitis
- growth inhibition
- headache
- hyperesthesia
- hypertrichosis
- hypothalamic-pituitary-adrenal (HPA) suppression
- impaired wound healing
- increased intracranial pressure
- infection
- irritability
- miliaria
- nasal congestion
- nasal dryness
- nasal irritation
- nasal septum perforation
- nausea/vomiting
- ocular hypertension
- ocular irritation
- pharyngitis
- pruritus
- purpura
- rhinalgia
- rhinorrhea
- sinusitis
- skin atrophy
- skin hypopigmentation
- skin ulcer
- sneezing
- striae
- telangiectasia
- tolerance
- urticaria
- visual impairment
- withdrawal
- xerosis
- xerostomia
Fluticasone Adverse Reactions
Fluticasone has a relatively low risk of hypothalamic-pituitary-adrenal (HPA) suppression when used at recommended doses. Pharmacologic doses of fluticasone administered for prolonged periods can, however, result in adrenocortical insufficiency. Manifestations of Cushing’s syndrome and hypothalamic-pituitary-adrenal (HPA) suppression with possible adrenocortical insufficiency and withdrawal symptoms after stopping treatment can occur if large doses of topical fluticasone are applied over extensive areas, under occlusive dressings, or for prolonged periods of time. Patients applying fluticasone to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. According to the manufacturer, systemic glucocorticoid adverse effects were not reported during clinical trials with fluticasone nasal spray or oral inhalation aerosol when administered at recommended doses. Symptoms of hypercorticism (e.g., Cushing’s syndrome) may occur if recommended doses of fluticasone are exceeded or if patients are particularly sensitive to the effects of fluticasone. Systemic absorption of fluticasone exerts a negative feedback effect on the pituitary, thereby inhibiting the secretion of adrenocorticotropin (ACTH). This results in a decrease in ACTH-mediated synthesis of endogenous corticosteroids and androgens by the adrenal cortex. The severity of glucocorticoid-induced secondary adrenocortical insufficiency varies among individuals and is dependent on the dose, frequency, time and route of administration, and duration of therapy. Patients with HPA suppression will require increased doses of corticosteroid therapy during periods of excessive stress. Post-marketing analysis show that Cushingoid features have been observed during clinical practice with the use of fluticasone propionate.
Adrenal suppression and growth inhibition have been observed in some children following therapy with high-dose fluticasone propionate. Post-marketing reports of growth inhibition (i.e., growth velocity reduction) in children and adolescents have been made with fluticasone propionate oral inhalation therapy, however incidence and frequency have not been determined. Children are also more prone to systemic adverse effects of topical fluticasone because of larger skin surface area-to-body weight ratio and thinner skin. Increased intracranial pressure has also been reported in children receiving topical corticosteroids; manifestations of increased intracranial pressure include bulging fontanelles, headaches, and bilateral papilledema. Growth inhibition has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients. With orally inhaled corticosteroids, the mean reduction in growth velocity is approximately one centimeter per year (range 0.3 - 1.8 cm per year) and appears to be related to the dose and duration of exposure. Children receiving 200 mcg per day of fluticasone nasal spray were found to have a point estimate for growth velocity of 0.14 cm/year lower than children receiving placebo (95% confidence interval ranging from 0.54 cm/year lower than placebo to 0.27 cm/year higher than placebo). While this was not a significant effect on growth each patient should be titrated to the lowest effective dose in order to minimize any effects of intranasal corticosteroids on growth. The long-term effects of this reduction in growth velocity, including the impact on final adult height, are unknown.
The most common adverse reactions occurring in > 1% of patients receiving intranasal fluticasone include epistaxis, nasal burning, bloody nasal secretions, headache, nasal irritation and itching, and pharyngitis. The frequency of nasal irritation was similar for the vehicle alone. Other adverse reactions occurring in < 1% of patients receiving intranasal fluticasone include bronchitis, dizziness, watery eyes (epiphora), rhinorrhea, nasal dryness, nasal congestion, nasal excoriation or ulcer, nausea/vomiting, sinusitis, sneezing, urticaria, and xerostomia. Nasal septum perforation is a rare, but severe complication of intranasal steroids. Common adverse reactions to oral inhalation of fluticasone include pharyngitis (10 - 14%), nasal congestion (8 - 16%), sinusitis (3 - 6%), dysphonia (3 - 8%), and headache (17 - 22%). Those adverse effects occurring in 1 - 3% of patients receiving orally inhaled fluticasone include arthralgia, bronchitis, chest congestion, dental problems, diarrhea, dizziness, dysmenorrhea, dyspepsia, fever, giddiness, ocular irritation, nausea/vomiting, rash/skin eruption, rhinalgia, and stomach disorder. The incidence of adverse reactions is increased with the administration of higher daily doses.
Secondary infection may be observed during topical or inhaled treatment with fluticasone. The anti-inflammatory activity of topical corticosteroids may also mask manifestations of infection. Local immunosuppression associated with inhaled fluticasone use may be manifested as an overgrowth of fungus in the nose, mouth, and throat. Oral candidiasis (thrush) is a well-known adverse reaction of oral inhalation steroid therapy and occurred in 2 - 5% of patients receiving inhaled fluticasone. The incidence may be correlated with daily dose, and appears to occur less frequently in children. Using an add-on spacer device, reducing the frequency of use, and rinsing the mouth following use may minimize the incidence of oropharyngeal thrush.
Inhaled corticosteroid therapy has been associated with the development of cataracts in adults. The risk of cataracts increases with long-term and high-dose inhaled corticosteroid use. The mechanism of corticosteroid-induced cataract formation is uncertain but may involve disruption of sodium-potassium pumps in the lens epithelium leading to accumulation of water in lens fibers and agglutination of lens proteins. Case reports describe visual impairment patients using topical corticosteroids for eczema of the face. The visual impairment was secondary to the onset of ocular hypertension. Such adverse effects, if they occur, could lead to blindness. Cataracts have also been reported, usually with large doses or therapy > 6 months. Any patient who develops changes in vision during topical corticosteroid therapy should be evaluated for ocular hypertension. Low potency corticosteroids (e.g., hydrocortisone, dexamethasone) have been reported to be safer for short-term use around the eye area.
Topical preparations of fluticasone may be associated with local adverse effects including acneiform rash, allergic contact dermatitis, folliculitis, hypertrichosis, maceration of the skin, miliaria, perioral dermatitis, pruritus, skin atrophy, skin hypopigmentation, striae, and xerosis. Other dermatologic effects include erythema, hyperesthesia, purpura, telangiectasia, and vesiculation. Tolerance may occur with the prolonged use of topical corticosteroid formulations. This may explain the dramatic responses noted initially by patients early in topical corticosteroid treatment and an apparent diminished response with time. Tolerance is reversible and may be attenuated by interrupted or cyclic schedules of application of fluticasone creams or ointments for chronic dermatologic conditions.
In general, excessive use of corticosteroids can lead to impaired wound healing. Fluticasone should not be applied directly or near healing wounds. A propensity for skin ulcer may develop in patients with markedly impaired circulation who use topical corticosteroids.
Hypersensitivity reactions occur rarely with fluticasone. Angioedema, urticaria, and bronchospasm have been reported with the use of inhaled fluticasone. Fluticasone inhalation powder contains lactose and has been associated, rarely, with anaphylactoid reactions, specifically in patients with milk protein hypersensitivity. Post-marketing reports state that very rare anaphylactic reactions in patients with severe milk allergies have been reported.
In rare cases, patients on inhaled fluticasone propionate may present with eosinophilia and clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition often treated with systemic corticosteroids. These events have happened most commonly in association with systemic corticosteroid withdrawal in conjunction with the introduction of inhaled fluticasone therapy. Patients presenting with eosinophilia, vasculitis with granulomas, worsening pulmonary symptoms, and/or neuropathy may have this condition, which may be severe. Similar cases have been reported with the use of other inhaled corticosteroids. A causal relationship to fluticasone has not yet been established, however, consistent with findings in clinical trails, systemic eosinophilic conditions have been reported in rare cases in patients on inhaled fluticasone propionate in post-marketing reports.
Several post-marketing adverse events have been reported with the use of inhaled fluticasone propionate. These events are reported voluntarily and frequency has not been determined. Events observed in clinical practice include: agitation, aggression, anxiety, aphonia, asthma exacerbation, bronchospasms, cataracts, chest tightness, contusions, depression, dyspnea, ecchymoses, facial and oropharyngeal edema, hyperglycemia, immediate bronchospasm, osteoporosis, pneumonia, restlessness, sore throat, and wheezing. Also noted, behavioral changes including hyperactivity and irritability were reported very rarely and primarily in children.
[ Last revised: 3/7/2006 6:16:00 PM ]
References
. Hanania NA, Chapman KR, Kesten S. Adverse effects of inhaled corticosteroids. Am J Med 1995;98:196 - 207.
. Todd G, Dunlop K, McNaboe J, et al. Growth and adrenal suppression in asthmatic children treated with high-dose fluticasone propionate. Lancet 1996;348:27 - 9.
. Cumming RG, Mitchell P, Leeder SR et al. Use of inhaled corticosteroids and the risk of cataracts. N Engl J Med 1997;337:8 - 14.
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