Flovent HFA (Fluticasone Propionate Inhalation) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Adolescent and Adult Patients

The incidence of common adverse events in Table 2 is based upon 2 placebo-controlled US clinical trials in which 812 adolescent and adult patients (457 females and 355 males) previously treated with as-needed bronchodilators and/or inhaled corticosteroids were treated twice daily for up to 12 weeks with 2 inhalations of FLOVENT HFA 44 mcg Inhalation Aerosol, FLOVENT HFA 110 mcg Inhalation Aerosol, FLOVENT HFA 220 mcg Inhalation Aerosol (dosages of 88, 220, or 440 mcg twice daily) or placebo.

Table 2. Overall Adverse Events With >3% Incidence in US Controlled Clinical Trials With FLOVENT HFA in Patients ≥12 Years of Age With Asthma Previously Receiving Bronchodilators and/or Inhaled Corticosteroids

Adverse Event	FLOVENT HFA 88 mcg Twice Daily (n = 203) %	FLOVENT HFA 220 mcg Twice Daily (n = 204) %	FLOVENT HFA 440 mcg Twice Daily (n = 202) %	Placebo (n = 203) %
Ear, nose, and throat
Upper respiratory tract infection	18	16	16	14
Throat irritation	8	8	10	5
Upper respiratory inflammation	2	5	5	1
Sinusitis/sinus infection	6	7	4	3
Hoarseness/dysphonia	2	3	6	<1
Gastrointestinal
Candidiasis mouth/throat & non-site specific	4	2	5	<1
Lower respiratory
Cough	4	6	4	5
Bronchitis	2	2	6	5
Neurological
Headache	11	7	5	6
Average duration of exposure (days)	73	74	76	60

Table 2 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in any of the groups treated with FLOVENT HFA 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 events were mostly mild to moderate in severity. Rare cases of immediate and delayed hypersensitivity reactions, including urticaria and rash, have been reported.

Other adverse events that occurred in the groups receiving FLOVENT HFA in these studies with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were:

Ear, Nose, and Throat

Sinusitis/sinus infection, rhinitis, pharyngitis/throat infection, rhinorrhea/post-nasal drip, nasal sinus disorders, laryngitis.

Gastrointestinal

Diarrhea, viral gastrointestinal infections, gastrointestinal signs and symptoms, dyspeptic symptoms, gastrointestinal discomfort and pain, hyposalivation.

Musculoskeletal

Musculoskeletal pain, muscle pain, muscle stiffness/tightness/rigidity.

Neurological

Dizziness, migraines.

Non-Site Specific

Fever, viral infections, pain, chest symptoms.

Skin

Viral skin infections.

Trauma

Muscle injuries, soft tissue injuries, injuries.

Urogenital

Urinary infections.

Fluticasone propionate inhalation aerosol (440 or 880 mcg twice daily) was administered for 16 weeks to patients with asthma requiring oral corticosteroids (Study 3). Adverse events not included in Table 2, but reported by >3 patients in either group treated with FLOVENT HFA and more commonly than in the placebo group included rhinitis, nausea and vomiting, arthralgia and articular rheumatism, musculoskeletal pain, muscle pain, malaise and fatigue, and sleep disorders.

In 2 long-term studies (26 and 52 weeks), treatment with FLOVENT HFA at dosages up to 440 mcg twice daily was well tolerated. The pattern of adverse events was similar to that observed in the 12-week studies. There were no new and/or unexpected adverse events with long-term treatment.

Pediatric Patients

FLOVENT HFA has been evaluated for safety in 56 pediatric patients aged 4 to 11 years who received 88 mcg twice daily for 4 weeks. Types of adverse events in these pediatric patients were generally similar to those observed in adults and adolescents.

Observed During Clinical Practice

In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing 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 a combination of heir seriousness, frequency of reporting, or potential causal connection to fluticasone propionate.

Ear, Nose, and Throat

Aphonia, facial and oropharyngeal edema, including angioedema, 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, anxiety, depression, and restlessness. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.

Respiratory

Asthma exacerbation, chest tightness, cough, dyspnea, immediate and delayed 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 (see PRECAUTIONS: Eosinophilic Conditions).

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO FLOVENT HFA

Possible Flovent HFA side effects / adverse reactions in 60 year old female

Reported by a individual with unspecified qualification from United States on 2007-01-03

Patient: 60 year old female weighing 79.4 kg (174.6 pounds)

Reactions: Exostosis, Oral Soft Tissue Disorder

Suspect drug(s):
Flovent HFA

Possible Flovent HFA side effects / adverse reactions in 2 year old male

Reported by a individual with unspecified qualification from United States on 2007-02-20

Patient: 2 year old male weighing 44.5 kg (97.8 pounds)

Reactions: Weight Increased, Coordination Abnormal, Ill-Defined Disorder

Suspect drug(s):
Advair Diskus 100/50
    Dosage: 1 puff 1 x day inhal
    Indication: Asthma
    Start date: 2005-06-01
    End date: 2006-09-01

Flovent HFA
    Dosage: 1 puff 2 x day inhal
    Indication: Asthma
    Start date: 2006-09-01
    End date: 2007-02-16

Possible Flovent HFA side effects / adverse reactions in 4 month old male

Reported by a physician from United States on 2007-06-12

Patient: 4 month old male weighing 17.3 kg (38.1 pounds)

Reactions: Flushing, Vomiting

Suspect drug(s):
Flovent HFA

Other drugs received by patient: Singulair; Rhinocort; Zyrtec