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advisory committee’s recommendation to do away with prescriptions for your 24-hour corticosteroid nasal spray just for seasonal and year-round nasal allergic reactions.
Triamcinolone is the 1st corticosteroid to gain an OTC acceptance, though other types of allergy treatments have been available that way for years.
Prescription triamcinolone was approved for allergic rhinitis in kids as young as 2 years in 2008. The OTC approval carried over to both adults and children ages two and older.
Many members of the advisory panel acquired expressed concern about use in kids, with some suggesting OTC approval for all adults but only prescription sales just for children.
The FOOD AND DRUG ADMINISTRATION requires that all intranasal and inhaled corticosteroid products carry warnings regarding growth suppression.
Extra warnings FDA briefing documents said would be required on the OTC content label were:
- Risk of local effects on the nasal cavity, ranging from infections to septal perforation
- Risk of cataracts or glaucoma, immune system repression, and hypothalamic pituitary adrenal axis suppression
- Stop use when severe or frequent nosebleeds or even persistent fever occur
- Consult a doctor before use in instances of a recent nasal ulcer, nasal surgery, or nasal injury which has not healed
The FDA approval was based on data submitted from 13 placebo-controlled efficacy studies, safety information from 43 clinical studies, and sixteen years of postmarketing surveillance data. The agency didn’t require further tests for nonprescription use, though Sanofi did study label comprehension and consumer understanding of growth effects, pump preparation, and safety concerns related to corticosteroids.
While various other portions of the FDA are closed due to the government shutdown, the company has continued activities supported simply by user fees, such as drug home loan approvals.
Triamcinolone is expected to be available OTC in spring 2014.
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