ADVERSE REACTIONS
Systemic and local corticosteroid use may result in the following:
- Epistaxis, ulcerations, Candida albicans infection, impaired wound healing [see Warnings and Precautions
]
- Cataracts and glaucoma [see Warnings and Precautions
]
- Immunosuppression [see Warnings and Precautions
]
- Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see Warnings and Precautions (5.5, 5.6), Use in Specific Populations
]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Allergic Rhinitis
Adults and adolescents 12 years of age and older
In controlled US and international clinical studies, a total of 3210 adult and adolescent patients 12 years and older with allergic rhinitis received treatment with NASONEX Nasal Spray 50 mcg at doses of 50 to 800 mcg/day. The majority of patients (n = 2103) were treated with 200 mcg/day. A total of 350 adult and adolescent patients have been treated for one year or longer. Adverse events did not differ significantly based on age, sex, or race. Four percent or less of patients in clinical trials discontinued treatment because of adverse events and the discontinuation rate was similar for the vehicle and active comparators.
All adverse events (regardless of relationship to treatment) reported by 5% or more of adult and adolescent patients ages 12 years and older who received NASONEX Nasal Spray 50 mcg, 200 mcg/day vs. placebo and that were more common with NASONEX Nasal Spray 50 mcg than placebo, are displayed in TABLE 1 below.
TABLE 1: ADULT AND ADOLESCENT PATIENTS 12 YEARS AND OLDER – ADVERSE EVENTS FROM CONTROLLED CLINICAL TRIALS IN SEASONAL ALLERGIC AND PERENNIAL ALLERGIC RHINITIS (PERCENT OF PATIENTS REPORTING)
|
NASONEX
200 mcg
(n = 2103) |
VEHICLE
PLACEBO
(n = 1671) |
| Headache |
26 |
22 |
| Viral Infection |
14 |
11 |
| Pharyngitis |
12 |
10 |
| Epistaxis/Blood-Tinged Mucus |
11 |
6 |
| Coughing |
7 |
6 |
| Upper Respiratory Tract Infection |
6 |
2 |
| Dysmenorrhea |
5 |
3 |
| Musculoskeletal Pain |
5 |
3 |
| Sinusitis |
5 |
3 |
Other adverse events which occurred in less than 5% but greater than or equal to 2% of adult and adolescent patients (ages 12 years and older) treated with NASONEX Nasal Spray 50 mcg, 200-mcg/day (regardless of relationship to treatment), and more frequently than in the placebo group included: arthralgia, asthma, bronchitis, chest pain, conjunctivitis, diarrhea, dyspepsia, earache, flu-like symptoms, myalgia, nausea, and rhinitis.
Pediatric patients <12 years of age
In controlled US and international studies, a total of 990 pediatric patients (ages 3 to 11 years) with allergic rhinitis received treatment with NASONEX Nasal Spray 50 mcg, at doses of 25 to 200 mcg/day. The majority of pediatric patients (n = 720) were treated with 100 mcg/day. A total of 163 pediatric patients have been treated for one year or longer. Two percent or less of patients in clinical trials who received NASONEX Nasal Spray 50 mcg discontinued treatment because of adverse events and the discontinuation rate was similar for the placebo and active comparators.
Adverse events which occurred in ≥5% of pediatric patients (ages 3 to 11 years) treated with NASONEX Nasal Spray 50 mcg, 100 mcg/day vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included upper respiratory tract infection (5% in NASONEX Nasal Spray 50 mcg group vs. 4% in placebo) and vomiting (5% in NASONEX Nasal Spray 50 mcg group vs. 4% in placebo).
Other adverse events which occurred in less than 5% but greater than or equal to 2% of pediatric patients (ages 3 to 11 years) treated NASONEX Nasal Spray 50 mcg, 100 mcg/day vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included: diarrhea, nasal irritation, otitis media, and wheezing.
The adverse event (regardless of relationship to treatment) reported by 5% of pediatric patients ages 2 to 5 years who received NASONEX Nasal Spray, 50 mcg, 100 mcg/day in a clinical trial vs. placebo including 56 subjects (28 each NASONEX Nasal Spray, 50 mcg and placebo) and that was more common with NASONEX Nasal Spray, 50 mcg than placebo, included: upper respiratory tract infection (7% vs. 0%, respectively). The other adverse event which occurred in less than 5% but greater than or equal to 2% of mometasone furoate pediatric patients ages 2 to 5 years treated with 100 mcg doses vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included: skin trauma.
Nasal Polyps
Adults 18 years of age and older
In controlled clinical studies, the types of adverse events observed in patients with nasal polyps were similar to those observed for patients with allergic rhinitis. A total of 594 adult patients (ages 18 to 86 years) received NASONEX Nasal Spray 50 mcg at doses of 200 mcg once or twice daily for up to 4 months for treatment of nasal polyps. The overall incidence of adverse events for patients treated with NASONEX Nasal Spray 50 mcg was comparable to patients with the placebo except for epistaxis, which was 9% for 200 mcg once daily, 13% for 200 mcg twice daily, and 5% for the placebo.
Nasal ulcers and nasal and oral candidiasis were also reported in patients treated with NASONEX Nasal Spray 50 mcg primarily in patients treated for longer than 4 weeks.
Nasal Congestion Associated with Seasonal Allergic Rhinitis
A total of 1008 patients aged 12 years and older received NASONEX Nasal Spray 50 mcg 200 mcg/day (n = 506) or placebo (n = 502) for 15 days. Adverse events that occurred more frequently in patients treated with NASONEX Nasal Spray 50 mcg than in patients with the placebo included sinus headache (1.2% in NASONEX Nasal Spray 50 mcg group vs. 0.2% in placebo) and epistaxis (1% in NASONEX Nasal Spray 50 mcg group vs. 0.2% in placebo) and the overall adverse event profile was similar to that observed in the other allergic rhinitis trials.
Post-Marketing Experience
The following adverse reactions have been identified during the post-marketing period for NASONEX Nasal Spray 50 mcg: nasal burning and irritation, anaphylaxis and angioedema, disturbances in taste and smell and nasal septal perforation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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