Avamys Adverse Reactions

AVAMYS nasal spray was well tolerated in adult, adolescent and paediatric subjects 2 years of age and older with seasonal allergic rhinitis and/or perennial allergic rhinitis over two- and six-week treatment periods. The compound was also well tolerated in longer term use over a period of 12 weeks in paediatric subjects and over a period of one year in adult and adolescent subjects.
Adverse Events: A summary of the adverse events occurring at an incidence of ≥3% and more frequently in the fluticasone furoate than placebo group in the adult and adolescents perennial allergic rhinitis long-term safety study (FFR102123) is provided as follows: See Table 2.

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Adverse Reactions: Data from large clinical trials were used to determine the frequency of adverse reactions. The following convention has been used for the classification of frequency: Very common ≥ 1/10, Common ≥ 1/100 and <1/10, Uncommon ≥ 1/1000 and <1/100, Rare ≥ 1/10,000 and <1/1000, Very rare <1/10,000.
Respiratory, thoracic and mediastinal disorders: Very Common: Epistaxis.
Epistaxis was generally mild to moderate in intensity. In adults and adolescents, the incidence of epistaxis was higher in longer term use (more than six weeks) than in short term use (up to six weeks). In paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between fluticasone furoate and placebo.
Common: Nasal ulceration.
Children: Not known: Growth retardation.
In a one-year clinical study assessing growth in pre-pubescent children receiving 110 micrograms of fluticasone furoate once daily, an average treatment difference of -0.27 cm per year (95% confidence interval: -0.48, -0.06 cm) in growth velocity was observed compared to placebo (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions).
Post Marketing Data: Immune system disorders: Rare: Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
Nervous system disorders: Common: Headache.
Respiratory, thoracic and mediastinal disorders: Uncommon: Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness.
Very rare: Nasal septum perforation.