Steroid Nasal Sprays Not Suitable For Rx-to-OTC Switch – Task Force

The potential for consumers to overdose on intranasal corticosteroids without physician guidance makes the drug category inappropriate for Rx-to-OTC switch, a recent task force report finds.

"The potential for overuse may be greater for intranasal corticosteroids, since they have a relative delayed onset of action, and patients may have a tendency to use a drug until they 'feel' an effect," according to the report published in the April Annals of Allergy, Asthma & Immunology.

"Since adverse effects are clearly dose-related, we consider the potential for overuse and complications from adverse effects as added incentive to oppose the over-the-counter release of this drug."

The findings were compiled by a joint task force organized by the American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma & Immunology. The position paper concentrates on potential safety issues when evaluating the release of intranasal corticosteroids for OTC use.

A joint FDA advisory committee meeting convened in March 2005 to discuss guidelines for future OTC topical corticosteroids (¹ (Also see "Topical Corticosteroid Switches Must Overcome Side Effect Concerns – Panel" - Pink Sheet, 28 Mar, 2005.), p. 3).

At the time, the Nonprescription Drugs and Dermatologic Drugs advisory committees determined that, when seeking an Rx-to-OTC switch, manufacturers would have to overcome a high burden of proof to convince FDA that side effects related to corticosteroids are outweighed by their benefits.

GlaxoSmithKline said in 2003 that it was actively considering a switch of its prescription nasal steroid spray Flonase (fluticasone propionate). However, the firm announced in February that it would instead work to block generic versions of the drug (² (Also see "GSK Flonase Switch Application Coming? Actual-Use Study Underway" - Pink Sheet, 22 Sep, 2003.), p. 4 and ³ (Also see "Flonase Generic Launch Blocked; Glaxo Drops Switch Plan" - Pink Sheet, 27 Feb, 2006.), p. 4).

Sanofi-Aventis' Nasacort (triamcinolone acetonide) also has been viewed as a potential switch candidate in the past.

The joint task force report focuses primarily on five different safety issues associated with nasal corticosteroid use: local and systemic effects of drugs in the category on growth, the eyes, the bones, and the hypothalamic-pituitary-adrenal (HPA) axis.

"After review of the available data, we concluded that intranasal corticosteroids should remain prescription-only drugs," Leonard Bielory, MD, New Jersey Medical School, Newark, N.J., et al., state.

For purposes of the position paper, Bielory et al. reviewed data on orally inhaled corticosteroids. Although the data demonstrating adverse effects was "stronger for orally inhaled corticosteroids," the authors note that the available information does not allow them "to state that use of intranasal corticosteroids is free of complications."

With this in mind, the authors still maintain that they found the risks of bone resorption, growth suppression and increased pressure in the eye to be significant.

"Based on our own analysis of the literature and these meta-analyses, it is clear that respiratory trace-administered corticosteroids can have clinically significant effects on bone" through their impact on bone density and fracture rate, they state.

Use of the drug also presents "an increased risk of adverse ocular effects," such as glaucoma and cataracts. Risk of these conditions increases with dose and duration of therapy, according to the report.

Even worse, adverse effects such as bone resorption and growth suppression "can be insidious...and therefore may not be evident for years or even decades," Bielory et al. maintain.

The task force cites "the inability to monitor the dose and adherence with intranasal corticosteroids (possibly permitting excessive exposure with self-dosing) and to teach appropriate self-administration or administration by a caregiver" as reason behind their ruling.

In addition, the authors note that rhinitis can be caused by overuse of topical nasal decongestant products. If intranasal corticosteroids were sold OTC, it would remove the "safeguard" of having the patient visit a pharmacist or health care provider to refill a prescription, they state.

These factors, combined with a lack of long-term data (spanning more than one year) regarding potential growth effects of the drugs, "make the over-the-counter transition of intranasal corticosteroids unsafe, unfeasible and undesirable," Bielory et al. conclude.

- Melina Vissat