Post analysis of SMART showed the African-American participants had more severe asthma (compared to Caucasians) at the start of the study.
The SMART study was not solely used as a basis for subsequent black box warnings, but the data from it formed the backbone for the FDA proceedings.
What's next for the FDA?
The FDA will decide whether any further warnings or restrictions should be made regarding labeling of the LABAs. Based on the above voting results, changes in labeling may be directed toward Serevent and Foradil (but probably not Advair or Symbicort).
There may also be further address of all these inhalants (including combination ones) in young children because of the small number of clinical studies in this age group.
The Take Home Message:
- 1) Advair and Symbicort remain as important agents for treating patients with moderate to severe persistent asthma, as expressed in the most recent (2007) revision of asthma management guidelines by the National Institute of Health.
- 2) Serevent and Foradil should not be prescribed as the only asthma inhaler for control, nor ever be used as quick-relief inhalers.
- 3) Young children (age 4-11) should be more carefully monitored for drug benefit and the presence of adverse effects from their asthma medications. Advair is the only combination inhaler approved in this age group.
Final Comments:
There will likely be many more postings and publications about Serevent, Advair, Foradil and Symbicort. If you are on one of these inhalers and have questions or concerns about what you read or hear be sure to discuss them with your doctor before taking any action.
In my experience, this relatively new class of inhalers has tremendously helped millions of people to control their asthma. Obviously the FDA advisory committee, NIH panel of experts, and many other allergist and pulmonologist feel the same way.
Questions or comments for Dr. Thompson? Click here.
Get more information on Advair, Symbicort and Long-Acting Beta Agonists here.
