ADVERSE REACTIONS
The incidence of common adverse events in Table 1 is based upon 7 placebo-controlled US clinical trials in which 1,243 patients (509 female and 734 male adolescents and adults previously treated with as-needed bronchodilators and/or inhaled corticosteroids) were treated with FLOVENT Inhalation Aerosol (doses of 88 to 440 mcg twice daily for up to 12 weeks) or placebo.
Table 1. Overall Adverse Events With >3% Incidence in US Controlled Clinical Trials With FLOVENT Inhalation Aerosol in Patients Previously Receiving Bronchodilators and/or Inhaled Corticosteroids
|
Adverse Event
|
Placebo
(N = 475)
%
|
FLOVENT
88 mcg
Twice Daily
(N = 488)
%
|
FLOVENT
220 mcg
Twice Daily
(N = 95)
%
|
FLOVENT
440 mcg
Twice Daily
(N = 185)
%
|
|
Ear, nose, and throat
|
|
|
|
|
|
Pharyngitis
|
7
|
10
|
14
|
14
|
|
Nasal congestion
|
8
|
8
|
16
|
10
|
|
Sinusitis
|
4
|
3
|
6
|
5
|
|
Nasal discharge
|
3
|
5
|
4
|
4
|
|
Dysphonia
|
1
|
4
|
3
|
8
|
|
Allergic rhinitis
|
4
|
5
|
3
|
3
|
|
Oral candidiasis
|
1
|
2
|
3
|
5
|
|
Respiratory
|
|
|
|
|
|
Upper respiratory infection
|
12
|
15
|
22
|
16
|
|
Influenza
|
2
|
3
|
8
|
5
|
|
Neurological
|
|
|
|
|
|
Headache
|
14
|
17
|
22
|
17
|
|
Average duration of exposure (days)
|
44
|
66
|
64
|
59
|
|
Table 1 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in groups treated with FLOVENT Inhalation Aerosol and were more common than in the placebo group. In considering these data, differences in average duration of exposure should be taken into account.
These adverse reactions were mostly mild to moderate in severity, with
Systemic glucocorticoid side effects were not reported during controlled clinical trials with FLOVENT Inhalation Aerosol. If recommended doses are exceeded, however, or if individuals are particularly sensitive, symptoms of hypercorticism, e.g., Cushing syndrome, could occur.
Other adverse events that occurred in these clinical trials using FLOVENT Inhalation Aerosol with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were: Ear, Nose, and Throat: Pain in nasal sinus(es), rhinitis.
Eye: Irritation of the eye(s). Gastrointestinal: Nausea and vomiting, diarrhea, dyspepsia and stomach disorder.
Miscellaneous: Fever.
Mouth and Teeth: Dental problem.
Musculoskeletal: Pain in joint, sprain/strain, aches and pains, pain in limb.
Neurological: Dizziness/giddiness. Respiratory: Bronchitis, chest congestion.
Skin: Dermatitis, rash/skin eruption.
Urogenital: Dysmenorrhea.
In a 16-week study in patients with asthma requiring oral corticosteroids, the effects of FLOVENT Inhalation Aerosol, 660 mcg twice daily (N = 32) and 880 mcg twice daily (N = 32), were compared with placebo. Adverse events (whether considered drug-related or nondrug-related by the investigator) reported by more than 3 patients in either group treated with FLOVENT Inhalation Aerosol and that were more common with FLOVENT than placebo are shown below: Ear, Nose, and Throat: Pharyngitis (9% and 25%), nasal congestion (19% and 22%), sinusitis (19% and 22%), nasal discharge (16% and 16%), dysphonia (19% and 9%), pain in nasal sinus(es) (13% and 0%), Candida-like oral lesions (16% and 9%), oropharyngeal candidiasis (25% and 19%). Respiratory: Upper respiratory infection (31% and 19%), influenza (0% and 13%). Other: Headache (28% and 34%), pain in joint (19% and 13%), nausea and vomiting (22% and 16%), muscular soreness (22% and 13%), malaise/fatigue (22% and 28%), insomnia (3% and 13%). Observed During Clinical Practice: In addition to adverse events reported from clinical trials, the following events have been identified during postapproval use of fluticasone propionate. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors. Ear, Nose, and Throat: Aphonia, facial and oropharyngeal edema, hoarseness, laryngitis, and throat soreness and irritation.
Endocrine and Metabolic: Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, osteoporosis, and weight gain.
Eye: Cataracts. Non-Site Specific: Very rare anaphylactic reaction.
Psychiatry: Agitation, aggression, depression, and restlessness. Respiratory: Asthma exacerbation, bronchospasm, chest tightness, cough, dyspnea, immediate bronchospasm, paradoxical bronchospasm, pneumonia, and wheeze.
Skin: Contusions, cutaneous hypersensitivity reactions, ecchymoses, and pruritus.
Eosinophilic Conditions: In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions, with some patients presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of fluticasone propionate. Cases of serious eosinophilic conditions have also been reported with other inhaled corticosteroids in this clinical setting. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal relationship between fluticasone propionate and these underlying conditions has not been established (see PRECAUTIONS: Eosinophilic Conditions).
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