What are the risks and considerations associated with long-term use of Flonase (fluticasone propionate)?

From the Guidelines

Long-term use of Flonase (fluticasone propionate) nasal spray is generally safe when used as directed, but it's crucial to monitor for potential risks and considerations, particularly the rare but possible suppression of the hypothalamic-pituitary-adrenal (HPA) axis and local side effects such as nasal irritation and bleeding, as noted in studies 1.

Key Considerations for Long-Term Use

• The most common local side effects include nasal irritation, nosebleeds, and headaches, which typically diminish over time.
• More concerning long-term risks include potential suppression of the HPA axis if excessive doses are used, though this is rare with standard nasal doses, as supported by research 1.
• Regular use may increase the risk of developing cataracts, glaucoma, or reduced bone mineral density over many years, but evidence from 1 suggests that long-term use has not been shown to affect systemic cortisol levels or increase the risk of lens opacity, elevated intraocular pressure, or other ocular symptoms.
• There's also concern about potential growth suppression in children, so their height should be monitored during treatment, with studies indicating that growth effects are dependent on the specific intranasal corticosteroid, dose, and administration technique 1.
• Some patients develop localized fungal infections (candidiasis) in the nasal passages or throat.

Recommendations for Safe Use

• Patients should use the lowest effective dose to minimize risks.
• Taking occasional "drug holidays" if possible can help reduce the risk of long-term side effects.
• Rinsing the mouth after use if any spray is swallowed is recommended.
• Regular eye exams and bone density screenings are advised if on prolonged therapy.
• Annual reassessment of symptoms and dosing is recommended to ensure the benefits continue to outweigh any potential risks, as suggested by the clinical practice guideline update for adult sinusitis 1.

From the FDA Drug Label

PRECAUTIONS General Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients... Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including fluticasone propionate. PRECAUTIONS: Pediatric use Use of excessive doses of corticosteroids may lead to signs or symptoms of hypercorticism and/or suppression of HPA function Patients using Fluticasone Propionate Nasal Spray, USP, over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa Intranasal corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract; untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections; or ocular herpes simplex

The long-term use of Flonase (fluticasone propionate) may be associated with several risks and considerations, including:

• Reduction in growth velocity in pediatric patients
• Increased risk of hypercorticism and adrenal suppression with excessive doses
• Candida infection or other adverse effects on the nasal mucosa with long-term use
• Nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure in rare instances
• Wheezing in rare instances It is essential to use Flonase with caution in patients with certain medical conditions, such as active or quiescent tuberculous infections, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex 2.

From the Research

Risks and Considerations

The long-term use of Flonase (fluticasone propionate) has been studied in several clinical trials. Some of the risks and considerations associated with its long-term use include:

• Epistaxis (nosebleeds), which was more frequently reported on active treatment compared to placebo 3
• Blood in nasal mucus, which was reported by significantly more patients in the two twice-daily active treatment groups compared with the placebo group 4
• Potential effects on the hypothalamic-pituitary-adrenal (HPA) axis, although studies have shown no evidence of HPA axis suppression with fluticasone propionate 4, 5
• Systemic corticosteroid exposure, although plasma concentrations of fluticasone furoate were not quantifiable in the majority of patients following intranasal administration 3

Efficacy and Safety

The efficacy and safety of fluticasone propionate have been compared to other treatments, such as beclomethasone dipropionate and antihistamines. Studies have shown that:

• Fluticasone propionate is as effective as twice daily dosing with beclomethasone dipropionate for perennial allergic rhinitis 4
• Fluticasone propionate aqueous nasal spray is superior to second-generation antihistamines in the management of allergic rhinitis 6
• Fluticasone propionate is well tolerated, with an adverse event profile similar to that of placebo, except for epistaxis 3

Long-term Use

The long-term safety of fluticasone furoate nasal spray has been assessed in a 12-month study, which found that:

• Fluticasone furoate was well tolerated, with no evidence of clinically relevant systemic corticosteroid exposure 3
• The incidence of most adverse events was similar to that observed with placebo, except for epistaxis 3