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Research Triangle Park, NC, May 8, 2003 - The Food and Drug Administration has approved revised labeling for Flonase Nasal Spray regarding its use in pediatric patients. The revision is based on results from a one-year clinical growth study that showed that Flonase, at the maximum recommended daily dose of 200mcg, had no statistically significant effect on growth compared to placebo.
The randomized, double-blind, placebo-controlled study of 150 pediatric patients (ages 3 to 9) found that children who were treated with Flonase demonstrated equivalent growth velocity and similar increases in height compared to those who received placebo. Also, there was no evidence of clinically significant effects on HPA axis function and bone density, additional measures of medication safety, in this study. The results of this study demonstrated that long-term use of fluticasone propionate - an intranasal corticosteroid with less than 2% bioavailability - at the maximum recommended daily dose, had no statistically or clinically significant effect on growth over the one-year treatment period in a pediatric population.1
"Historically, the potential for intranasal corticosteroid therapy for nasal allergies with older, more bioavailable products to affect growth in children has been cause for concern," said Dr. Edward Philpot, senior director of allergy in Clinical Development and Medical Affairs at GlaxoSmithKline. "This approved labeling change based on the study findings further reinforces the safety and efficacy of intranasal fluticasone propionate in pediatric patients with nasal allergies, with no adverse effect on growth, even with long-term use over the one-year period."
The indication for Flonase remains unchanged.
Over the one-year treatment period, 12% of patients in each treatment group reported at least one adverse event that was considered to be at least possibly related to study medication. The most commonly occurring drug-related adverse event, epistaxis (nosebleed), was reported among 9% of the group using Flonase and 8% of the group using placebo. No adverse events indicative of systemic drug exposure were reported.1
Controlled clinical studies have shown that some intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. The growth of pediatric patients receiving intranasal corticosteroids, including Flonase Nasal Spray, should be monitored routinely (e.g., via stadiometry).
About Flonase (fluticasone propionate) Nasal Spray, 50mcg
Flonase Nasal Spray is an intranasal corticosteroid spray that helps reduce inflammation and relieves the nasal symptoms associated with seasonal and perennial allergic and non-allergic rhinitis in patients ages 4 and above. Flonase is the only aqueous nasal spray approved to treat the nasal congestion associated with seasonal allergic rhinitis and perennial allergic and non-allergic rhinitis in patients as young as 4 years of age. In fact, Flonase treats more triggers than any leading allergy medicine.
Flonase received FDA approval for marketing in 1994.
For best results, Flonase should be used daily. Results may vary. If side effects occur, they are generally mild and may include headache, nosebleed and sore throat. Flonase Nasal Spray is available by prescription only.
GlaxoSmithKline, one of the world's leading research-based pharmaceutical and health care companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. The company is an industry leader in respiratory research and has a broad portfolio of commercially available respiratory therapies
Please consult full complete prescribing information.
For prescribing information or more information, please contact Robin Gaitens at GlaxoSmithKline, (919) 483-2839.
Reference
1. Allen DB, et al. "No growth suppression in children treated with the maximum recommended dose of fluticasone propionate aqueous nasal spray for one year." Allergy and Asthma Proc 23:407-413, 2002.
| GlaxoSmithKline contact |
Robin Gaitens |
(919) 483-2839 |
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