SILVER SPRING, Md. -- An FDA advisory committee voted Wednesday to make allergy nasal spray triamcinolone acetonide (Nasacort AQ) available without a prescription -- but many committee members voiced concern about its use in children.
The FDA's Nonprescription Drugs Advisory Committee voted 10-6, with two members abstaining, to switch triamcinolone, a corticosteroid, from a prescription-only product to being available for over-the-counter (OTC) sales.
Multiple panel members cited a lack of data on widespread use in children or concerns about corticosteroids' growth suppression.
French drugmaker Sanofi is seeking to transition triamcinolone -- 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.
The FDA requires class-wide warnings about corticosteroids' growth suppression for both intranasal and inhaled products.
A post-marketing study of 299 children ages 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%).
"I voted No out of concern for inadequate data and duration of data to inform the growth issues, and I believe that the best way to address that is going to be through longer actual use studies and changes to the label," said committee chair Richard Neill, MD, chief of family medicine at Penn Presbyterian Medical Center in Philadelphia.
Michael Paasche-Orlow, MD, MPH, professor at the Boston University School of Medicine, abstained but said he supported OTC sales for adults and a prescription for children.
FDA reviewers said this week triamcinolone acetonide is a "good candidate" for the treatment of seasonal and perennial allergic rhinitis in an OTC setting.
Some panelists didn't express the same level of concern with growth suppression.
"I don't see a safety signal given what we've heard," said Ruth Parker, MD, professor of pediatrics and public health at Emory University School of Medicine in Atlanta, who voted Yes. However, "there's insufficient data to be certain about the safety in less-than-2-year-olds."
Those concerned with height noted growth is the most sensitive marker of other safety issues, but those safety issues weren't entirely clear.
Maria Pruchnicki, PharmD, professor at the Ohio State University College of Pharmacy in Columbus, voted Yes but shared concerns about use in patients under 18 because of growth issues.
"I would like to see maybe a labeling change where healthcare providers can be a source of that information to patients, and maybe the company can focus on education efforts to highlight those areas of concern," she said.
Other safety concerns the FDA noted included nosebleeds, immunosuppression, glaucoma, and septal perforation -- but even the agency said those issues weren't a big deal.
Committee members were also unsure in what manner the product would be used over the counter and without supervision by a healthcare provider. Their concerns included overdosing, using the drug to treat colds, and consumers knowing when to stop taking the product. Others were concerned people wouldn't consult their physicians when taking the more risky corticosteroid as a nasal allergy spray.
, 96.6% (95% CI: 93.9-98.3%) understood instructions in the proposed label to tell your child's doctor when a child starts 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.
Nasal steroids also have been used safely for years when obtained via prescription, and there was no need to re-establish efficacy, FDA reviewers said.
The FDA didn't require a self-selection or actual use study, which it sometimes requires in OTC switches.
The FDA isn't obligated to follow the advice of its advisory committees, but usually does. Sanofi expects an FDA decision by this fall.