Umeclidinium and Vilanterol Oral Inhalation
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(ue me'' kli din' ee um) and (vye lan' ter ol )
- Anoro Ellipta® (as a combination product containing umeclidinium, vilanterol)
In a large clinical study, more people who used an asthma medication similar to vilanterol experienced severe episodes of asthma that had to be treated in a hospital or caused death than patients who did not use the medication. Use of vilanterol inhalation may increase the risk of serious asthma problems or death in people who have asthma. Umeclidinium and vilanterol inhalation has not been approved by the Food and Drug Administration (FDA) for the treatment of asthma. There is not enough information to tell whether inhaling umeclidinium and vilanterol increases the risk of death in people who have chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, which includes chronic bronchitis and emphysema).
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with umeclidinium and vilanterol and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.
Talk to your doctor about the risks of using this medication.