In May, the FDA approved a new dry powder inhaler, named Breo Ellipta, and it might change the lives of some patients suffering with COPD. The purposes of this new drug are “to increase airflow and reduce exacerbations in patients with chronic obstructive pulmonary disease.”
This is a maintenance drug, and it must be inhaled every day. The medicine is a combination of corticosteroid fluticasone furoate with vilanterol. Vilaterol is a “long-acting β2-adrenergic agonist (LABA).”
A study of 7700 COPD patients was conducted prior to the FDA announcement. In simple terms, those patients who were treated with Breo Ellipta “had improved lung function.” Likewise, their number of exacerbations lessened, when compared with those on placebo.
Breo Ellipta will carry a warning concerning the notoriety of its increased risk for asthma-related death. Here are some of the finer points:
1. The drug will not be used for patients younger than 18 years.
2. The drug is not approved for Asthma.
3. Caution! This is not a “rescue” therapy for acute bronchospasm. With benefits, there also come side effects, in the use of any drug. Here is a short list of possible side effects from Breo Ellipta: You might have to endure headache, nasopharyngitis, thrush, and upper respiratory tract infections. We are sad to note that drug also increases the risks for both bone fractures and pneumonia. Just the same, when you balance enduring side effects against gasping for air, most people will choose air.
Other notes we found of interest on the new drugs label include:
1. Monitor patients for signs and symptoms of pneumonia.
2. Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex).
3. Risk of impaired adrenal function when transferring from systemic corticosteroids.
4. The FDA also reminded health care providers to taper patients slowly from systemic corticosteroids when changing to BREO ELLIPTA.
5. If paradoxical bronchospasm occurs, discontinue BREO ELLIPTA and replace with alternative therapy
6. Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.
7. Assess for decrease in bone mineral density initially and periodically thereafter.
8. Also recommended was close monitoring for glaucoma and cataracts. Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
9. Be alert to hypokalemia and hyperglycemia.
Find these and other special notes at this excellent source.
As in the case of this story, the Florida Lung Doctors have been publishing blog articles featuring medical research studies from all over the globe. Did you know that the Florida Lung Doctors also have their own clinical research program? We will soon bring you information about The Florida Lung Doctors’ Clinical Studies, and the far reaching effects of the data they collect.