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Information for Patients Taking Advair, Dulera, Symbicort, Serevent or Foradil
The FDA “Black Box” Warning: The Controversy Surrounding Long-Acting Beta-Agonists
The William Storms Allergy Clinic
The long-acting bronchodilators (LABA) Serevent (salmeterol) and Foradil (formoterol) have been used for asthma for more than 10 years. Advair and Symbicort both combine a LABA and an inhaled corticosteroid. Advair contains Serevent; Symbicort and Dulera contain Foradil.
In 2004, the FDA issued a warning which states that a study showed “a small but significant increase in asthma-related deaths in patients receiving salmeterol versus those on placebo.” The study showed that African Americans were more likely to have an adverse outcome than Caucasians. It should be noted that in the study, none of these patients were on Advair, Dulera or Symbicort. Many study patients were not on any inhaled steroid, just on Serevent.
In patients with persistent asthma, Advair is the most popular daily therapy in the U.S. and Europe. In recent years, it has been favored over using inhaled corticosteroids alone, such as Flovent, Pulmicort, QVAR, Azmacort, or Asmanex because patients feel better rapidly and lower doses of inhaled corticosteroids can be used. Many physicians continue to use Advair, Symbicort and Dulera with confidence.
Why does a medicine that is usually beneficial cause problems in a very few patients? It is likely that a genetic difference found in African-Americans plays some role, but there is no way to predict a poor outcome.
WHAT THE WILLIAM STORMS ALLERGY CLINIC RECOMMENDS:
My approach is to continue to use LABAs, Advair, Dulera and Symbicort in more severe asthmatics, while utilizing “monotherapy” with inhaled corticosteroids alone in milder asthmatics. If you are on low dose Advair, Dulera or Symbicort and doing well, you can make an appointment and we will discuss your current treatment needs, but you may choose not to do so.
In summary, there is reason for both patients and physicians to be concerned whenever the FDA issues a warning. For the majority of asthmatics, LABAs are probably safe, but a small subset may do poorly. If you have concerns about your or your family’s asthma treatment program, please make an appointment and we will review your options. While we believe the “black box warning” to apply only to a few patients, we will continue to be cautious and try to avoid any potential problems.
Do NOT stop your asthma medicines without talking to us first. Untreated asthma poses a much greater risk than using long-acting bronchodilators.
Please feel free to share this newsletter with friends and neighbors who have asthma and may also be using medications covered in this warning.