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Fluticasone propionate (top)
and salmeterol (bottom)
|Salmeterol||Long-acting β2 agonist (LABA)|
|Trade names||Advair, Seretide|
Patent protection in the US expired in 2010, and European patent protection expired in 2013. However, the availability of a generic form of Advair in the United States may be significantly delayed because the Food and Drug Administration has not determined a standard for the bioequivalence of inhaled steroids in multi-dose inhalers or dry powder inhalers.
Fluticasone, a corticosteroid, is the anti-inflammatory component of the combination which decreases inflammation in the lungs which can lead to better breathing. Salmeterol, a long acting beta-adrenoceptor agonist (LABA), treats constriction of the airways. Both combined are meant to be used as maintenance therapy and not as a rescue therapy for sudden symptoms. Together, they help prevent symptoms of coughing, wheezing and shortness of breath.
The common and minor side effects of this combination are those of its individual drugs. For instance, the use of inhaled corticosteroids is associated with oral candidiasis (commonly known as yeast infection, or thrush). It is recommended to rinse and gargle with water after inhaling the medication. This decreases the risk of developing a candidiasis infection.
Whilst the use of inhaled steroids and long acting beta-adrenoceptor agonists (LABA) are recommended in asthma guidelines for the resulting improved symptom control, concerns have been raised that salmeterol may increase the small risks of asthma deaths and this additional risk is not reduced with the additional use of inhaled steroids. Other side effects from this drug combination may include increased blood pressure, change in heart rate, an irregular heartbeat, increased risk of osteoporosis, cataracts, and glaucoma. With available studies, the safety of inhaled fluticasone propionate cannot be questioned for its effect on growth of asthmatic children. A systematic review published in year 2013, could not derive any significant adverse effect on HPA function, growth and bone mineral density in asthmatic children when inhaled fluticasone is used for long duration and followed for up to three months.
Although Advair lost US patent protection in 2010, no generic equivalent is imminent in the US. On November 8, 2010, Teva Pharmaceutical Industries said the regulatory hurdles were too high for a US generic. Teva said they would work on a branded competitor that should be ready by 2014 and might receive US approval by 2016.
In 2012, Advair was part of a larger civil settlement agreement between GlaxoSmithKline (GSK) and the United States, in which GSK agreed to pay $1.043 billion; the United States said that GSK promoted off-label uses of Advair and paid kickbacks to healthcare professionals to sell this drug, among others.
- "Guideline 101: British Guideline on the Management of Asthma". British Thoracic Society & Scottish Intercollegiate Guidelines Network (SIGN).
- Salpeter SR, Buckley NS, Ormiston TM, Salpeter EE (June 2006). "Meta-analysis: effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths". Ann. Intern. Med. 144 (12): 904–12. doi:10.7326/0003-4819-144-12-200606200-00126. PMID 16754916.
- "US futicasone propionate/Salmeterol label" (PDF). FDA. April 2016.
- Muley, Prasad; Shah, Monali (2013). "Safety of Inhaled Fluticasone Propionate Therapy for Pediatric Asthma - A Systematic Review". Current Drug Safety. 8 (3): 186-194. PMID 23859431.
- Biospace.com 11/8/2010
- "GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data". Department of Justice: Office of Public Affairs. July 2, 2012.