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FDA Public Health Advisory: Long-acting beta 2-adrenergic agonists

November 18, 2005

Serevent Diskus (salmeterol xinafoate inhalation powder)
Advair Diskus (fluticasone propionate & salmeterol inhalation powder)
Foradil Aerolizer (formoterol fumarate inhalation powder)

Today, FDA requested manufacturers of Advair Diskus, Foradil Aerolizer, and Serevent Diskus to update their existing product labels with new warnings and a Medication Guide for patients to alert health care professionals and patients that these medicines may increase the chance of severe asthma episodes, and death when those episodes occur. All of these products contain medicines belonging to the class known as "long-acting beta 2-adrenergic agonists"(LABA), which are long-acting bronchodilator medicines. Bronchodilator medicines, such as LABAs, help to relax the muscles around the airways in the lungs. Wheezing (bronchospasm) happens when the muscles around the airways tighten. Even though LABAs decrease the frequency of asthma episodes, these medicines 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.
  • Do not stop using your LABA or other asthma medicines that your health care professional has prescribed for you unless you have discussed with your health care provider whether or not to continue treatment.
  • Do not use your LABA to treat wheezing that is getting worse. Call your health care professional right away if wheezing worsens while using a LABA.
  • LABAs do not relieve sudden wheezing. Always have a short acting bronchodilator medicine with you to treat sudden wheezing.

The information in FDA's proposed changes to the product labels explains that, even though LABAs decrease the number of asthma episodes, these medicines may increase the chances of a severe asthma episode when they do occur. 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.

LABAs are used for long-term control and prevention of asthma symptoms, for preventing wheezing (bronchospasm) caused by exercise in adults and children and for long-term control of wheezing (bronchospasm) in adults with chronic obstructive pulmonary disease. 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.

Source: FDA

Posted: November 2005