WASHINGTON -- FDA staff reviewers had few questions about making allergy nasal spray triamcinolone acetonide (Nasacort AQ) available for over-the-counter (OTC) sales; later this week an advisory committee will look at the issue.

Triamcinolone acetonide (TAA) is a "good candidate" for the treatment of seasonal and perennial allergic rhinitis in an OTC setting, FDA staff reviewers said in documents released ahead of Wednesday's Nonprescription Drugs Advisory Committee meeting on the product.

French drugmaker Sanofi is seeking to transition its corticosteroid -- approved in 1996 and currently labeled for adults and children ages 2 and older -- to an OTC product to treat hay fever and other upper respiratory allergies.

As with all Rx-to-OTC switches, the FDA asks if consumers are able to understand the product's label, self-diagnose their condition, and safely use the product. Other allergic rhinitis products such as oral antihistamines, oral and nasal spray decongestants, and nasal spray chromones have been used OTC for years.

"Therefore it is reasonable to conclude that consumers should be able to self-diagnose and self-select to use TAA nasal spray based solely on information provided on the TAA nasal spray drug facts label," the reviewers said.

Nasal steroids also have been used safely for years when obtained via prescription.

"There is no need to re-establish efficacy, since if used according to the labeled directions nasal steroids should provide a similar degree of symptomatic improvement whether in the prescription or OTC setting," the agency reviewers added.

However, the drugmaker did study label comprehension and consumer understanding of growth effects, pump preparation, and safety concerns related to corticosteroids. Nasacort AQ would be the first corticosteroid available without a prescription.

In a study of 475 consumers, 96.6% (95% CI: 93.9-98.3%) understood instructions in the proposed label to tell your child's doctor when they start using the product. Fewer consumers -- 78.7% (95% CI: 73.7-83.1%) -- understood instructions that the medication may temporarily slow the rate of growth in some children.

The FDA requires a class-wide warning for inhaled and intranasal corticosteroids saying they hinder children's growth. A post-marketing study of 299 children on triamcinolone acetonide found those age 3 to 9 showed a 0.45 cm/year drop in growth velocity at 1 year in those taking the drug compared with a placebo group (95% CI: 0.78-0.11%).

"While acknowledging that fewer correctly responded to the message about temporarily slowing in the rate of growth, [Sanofi] states that the physician can provide counsel regarding the potential for growth effects if consumers follow the direction to inform the child's doctor," the briefing documents stated.

Intranasal corticosteroids can have local effects on the nasal cavity ranging from infections to septal perforation. The OTC product's label will contain additional warnings about stopping use if the user has severe or frequent nosebleeds or persistent fever.

"The consumer is also instructed to ask a doctor before use if he has had a recent nasal ulcer, nasal surgery or nasal injury that has not healed," the reviewers wrote.

Corticosteroids also may result in cataracts or glaucoma, immune system repression, and hypothalamic pituitary adrenal axis suppression. Therefore, the drug facts label will be reflective of such warnings, and also warn that the drugs can hinder children's growth.

In Sanofi's study of consumer understanding, between 83% and 98% of consumers correctly understood these warnings and how to handle them.

At Wednesday's meeting, members of the FDA advisory committee will vote on recommending an OTC switch and discuss possible labeling and warnings for the product.