Patients suffering from chronic obstructive pulmonary disorder, often called smoker's cough can now heave a sigh of relief. The FDA has given the green signal to the Breo Ellipta inhaler for long-term use for this indication.
Developed by GlaxoSmithKline, Research Triangle Park, N.C., in collaboration with San Francisco-based Theravance, Breo Ellipta comes as a combination of two drugs (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients suffering from chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It works by reducing inflammation in the lungs and relaxing airways to ease breathing.
COPD is a serious lung disease, deteriorating over time, with symptoms that include chest tightness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute, and COPD is the third leading cause of death in the United States. In excess of 12 million Americans are currently diagnosed with COPD, and another 12 million may have COPD without being aware of it. It is critical that anyone with symptoms of chronic cough, shortness of breath or wheezing, see their doctor or health care provider for a simple breathing test, followed by prompt treatment.
The agency cleared the Breo Ellipta inhaler which consists of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), based on favorable clinical studies. The safety and efficacy studies of Breo Ellipta in 7,700 patients afflicted with COPD showed improved lung function and reduced flare-ups compared to patients not receiving the intervention.
However, the medication is not without its dose of warnings. Patients should note that these type of medicines called LABAs raise the risk of asthma-related death. It is important therefore, that the safety and efficacy of Breo Ellipta is evaluated in patients with asthma. In any case, it is not approved for the treatment of asthma, just yet.
It is critical that patients use the FDA- approved Breo Ellipta after reading the patient medication guide for instructions for use and learn more about the potential risks of taking the drug. Breo Ellipta use is associated with serious side effects, including increased risks of pneumonia and bone fractures. The most common side effects include inflammation of the nasal passage (nasopharyngitis), upper respiratory tract infection, headache, and oral candidiasis (thrush), according to the FDA release.
In particular, Breo Ellipta is not recommended as a rescue therapy to treat sudden breathing problems (acute bronchospasm). It is also not meant for people younger than 18 years.
