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Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch-up” growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including Fluticasone Propionate Nasal Spray, should be monitored routinely (. via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including Fluticasone Propionate Nasal Spray, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

Another well-controlled clinical study evaluated 279 subjects with mild to moderate plaque-type psoriasis (mean Body Surface Area at baseline was % with a range from 1% to 20%) of non-scalp regions. Subjects were treated twice daily for 2 weeks with OLUX (clobetasol propionate) Foam or Vehicle foam. The face and intertriginous areas were excluded from treatment. The efficacy of OLUX (clobetasol propionate) Foam in treating non-scalp psoriasis at the end of 2 weeks' treatment was superior to that of Vehicle foam. See Table 2 below.

In a 90-day repeat-dose toxicity study in rats, topical administration of clobetasol propionate foam at dose concentrations from % to % or from to mg/kg/day of clobetasol propionate resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organs systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk for carcinogenesis.

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