FDA Public Health Advisory

On November 18, 2005, the FDA requested that manufacturers of Long Acting Bronchodilator medications update their existing product labels with new warnings and a Medication Guide for patients to alert both health care professionals and patients that these medicines may increase the chance of severe asthma episodes, and death when those episodes occur. Even though these Long Acting Bronchodilator medications (LABA) decrease the frequency of asthma episodes, they may make asthma episodes more severe when they occur.

FDA is issuing this public health advisory to highlight recommendations about use of a LABA medicine for asthma:

• LABAs should not be the first medicine used to treat asthma. LABAs should be added to the asthma treatment plan only if other medicines do not control asthma, including the use of low-or-medium dose corticosteroids.
• The public is advised not to stop using LABA or other asthma medications until they have discussed their treatment regimen with their health care provider.
• The public is advised not to use LABAs to treat wheezing that is getting worse. Rather, they are advised to contact their health care professional immediately if wheezing worsens while using a LABA.
• Because LABAs do not relieve sudden wheezing, patients are advised to always have a short acting bronchodilator medicine available to treat sudden wheezing.

In one asthma medicine study, an increased number of people taking a LABA in addition to their usual asthma care died from their asthma compared to people taking a placebo in addition to their usual asthma care, although the number of asthma deaths in the study was small. The Medication Guide has information about these risks for patients and caregivers in language approved by FDA and will be given to patients when a prescription for a LABA is filled or refilled. The new warnings are about LABA-use for asthma. Information is not available to know whether there are similar concerns when LABAs are used for exercise-induced wheezing (bronchospasm) or chronic obstructive pulmonary disease.