Search

Self Care Pharmacy Blog

Archive for the ‘Allergies/Cold’ Category

 

Nasacort: OTC Status Approve or Disapprove?

Tuesday, October 8th, 2013

By Nathanael Smith, PharmD Student Cedarville University

Allergic Rhinitis (AR) is a systemic disease with prominent nasal symptoms that affects the upper respiratory system, causing symptoms of itching of the eyes, nose and/or palate and sinus pain. AR is a disorder triggered by indoor and/or outdoor allergens that is characterized by the activation of IgE, a inflammatory immunoglobulin.1 Indoor allergens consist of house-dust mites, mold, cockroaches, and pet dander. Outdoor allergens consist of mold spores, pollen, and possible pollutants such as exhaust particles. The allergen enters the body and causes a complex four-phase effect involving histamines and other inflammatory mediators that eventually lead to inflammation and an overproduction of mucus. This disease affects worldwide populations of adults and children. It is estimated that 20% of adults and 40% of children in the United States have this disease, coupled with a steady increase in cases over the past 3 decades.3

 CNBC covered a story about Sanofi SA, a pharmaceutical company, who was attempting to move prescription Nasacort AQ to be an over-the-counter medication. Nasacort AQ is an intranasal corticosteroid (INC) aerosol that provides effective relieve for AR. The FDA advisory panel voted 10-6 for the move of Nasacort, but the FDA has not given the OK to make the switch.4 Sonafi SA wants the approval because Teva pharmaceuticals has won the rights to manufacture the generic.4 This caused a decrease in gross for Sanofi of approximately $275 million dollars, dropping from $375 million to $100 million sales in one year.4 Sanofi is hoping that the switch to a nonprescription medication will increase the revenue for Nasacort and help compensate for the loss of sales.4

The appropriateness of the switch, however, is not based on the revenue that the company can make, but on how effective the medication is and the safety of the medication for self-care use. According to the Journal of Rhinology and Allergy (AJRA), all INCs, such as Flonase, Nasonex, and Nasacort, are equally effective and potentially better at relieving allergic rhinitis in adults and pediatrics as antihistamines. In addition, the AJRA states that INCs are considered the “most effective first-line therapy to improve AR symptoms and burden of disease.” On the flip side, articles opposing INCs becoming OTC medications were written due to the use of new aqueous propellants that caused several side effects such as “dripping down the throat,” and “wet feeling,” along with pharyngitis and nasal burning/irritation.5 To relieve these adverse effects, numerous studies have been done to help make INCs safer including the use of nonaqueous propellants such as hydrofluoroalkane (HFA).5 Now, after numerous studies, INCs have much better side effects, only consisting of throat/nose irritation or dryness, coughing, sneezing, nose bleeds, or unpleasant taste/smell.6 On top of this, intranasal corticosteroids have less side effects than oral antihistamines and are therefore the recommended choice in both adults and children with persistent allergic rhinitis.7

In light of the article background and information regarding INC medications, I agree with this article. INCs, such as Nasacort, are the “gold standard” for choice due to the safety and effectiveness of the medication in treating allergic rhinitis.8 In addition, the American Academy of Family Physicians (AAFP) stated that INCs are the first line option for all mild-moderate persistent AR in children and adults, while antihistamines, such as Zyrtec, Claritin, and Allegra, are more for occasional allergies.9 In addition, INCs were shown in 11 studies to provide greater relief to itching and nasal blockage than oral antihistamines.10 Therefore, this new proposal for Nasacort to be moved to an OTC medication would change my self-care recommendation. My first choice for a patient would depend upon the symptoms the patient was showing. If a patient solely had a complaint of a first-time allergy that occurred at irregular times, I would recommend an oral antihistamine. If the patient, however, showed symptoms of persistent, mild to moderate allergies, or needed a safe, fast relief, then I would first recommend Nasacort. In the end, Nasacort has shown to provide better results and safer action than other allergy medications.   

Intranasal corticosteroids have evolved significantly over the past seven years due to opposition on efficacy. This evolution has brought about safer products that can be the most effective response to allergic rhinitis symptoms. Eventually, Nasacort may become an OTC medication, and pharmacists will need to counsel patients on the proper self treatment, and whether or not the patient should use an INC instead of a different allergy medication.

With this potential switch, do you feel comfortable using Nasacort instead of the common oral antihistamines? Would you suggest this product to a friend or relative that may be suffering from persistent allergies?

 

References:

 

[1] Mucci T, Govindaraj S, Tversky J. Allergic rhinitis. Mt Sinai J Med. 2011;78(5):634-644.

 

[2] Blaiss MS. Allergic rhinitis: Direct and indirect costs. Allergy Asthma Proc. 2010;31(5):375-380.

 

[3] Krinsky, D. Berardi, R. Ferreri, S. Hume, A. Newton, G. Rollins, C. Tietze, K. Scolaro, K. Disorders related to colds and allergy. In: Wolter KY, L., ed. Handbook of nonprescription drugs. 17th ed. ; 2012:190-201.

 

[4] Dooren J. FDA: Sanofi allergy spray ‘good candidate’ for nonprescription switch. WSJ. 2013.

 

[5] Carr WW. New therapeutic options for allergic rhinitis: Back to the future with intranasal corticosteroid aerosols. Am J Rhinol Allergy. 2013;27(4):309-313.

 

[6] Triamcinolone acetonide – nasal, nasacort. Medicine Net.com Web site. http://www.medicinenet.com/triamcinolone_acetonide-nasal/article.htm. Updated 2013. Accessed October 4, 2013.

 

[7] Salib RJ, Howarth PH. Safety and tolerability profiles of intranasal antihistamines and intranasal corticosteroids in the treatment of allergic rhinitis. Drug Safety. 2003;26(12):863.

 

[8] Blaiss MS. Safety update regarding intranasal corticosteroids for the treatment of allergic rhinitis. Allergy Asthma Proc. 2011;32(6):413-418.

 

[9] Sur D, Scandale S, Geffen D. Treatment of allergic rhinitis. AAFP. 2010;81(12):1440-1446.

 

[10] Weiner J, Abramson M, Puy R. Intranasal corticosteroids versus oral H1 receptor antagonists in allergic rhinitis: Systematic review of randomised controlled trials. BMJ. 1998;317(7173):1624-1629.