• Advair and Symbicort – “Black Box Warnings”

    01Jun
    Categories: Uncategorized Comments: 5

    In 2003, the FDA required the manufacturer of Advair to include a “Black Box Warning” on the package insert of this medication. The reason for this was due to the finding in a large trial that some patients with asthma who were treated with the long-acting bronchodilator, salmeterol, had a higher incidence of asthma related death and other complications from asthma than the group who was not treated with salmeterol. Since 2003 there have been further analyses and studies regarding the use of salmeterol and another long-acting bronchodilator, formoterol. Formoterol is used in the medications Foradil and Symbicort.
    Opinions among experts have been polarized. Some well-respected physicians have stopped using these drugs altogether in favor of using higher doses of steroids as well as older medications such as theophylline for treatment of moderate and severe asthma. Others who are equally well respected cite data referring to the overall safety of long-acting bronchodilators salmeterol and formoterol, and continue to use them.
    The FDA has recently updated its labeling regarding the use of long-acting bronchodilators. They have concluded that the benefits of these drugs for asthma treatment outweigh the risks, when used appropriately, but that they should be used only in patients whose asthma cannot be controlled with controller medications such as inhaled corticosteroids alone. The new label stipulates that long-acting bronchodilators should only be used along with a concurrent controller medication. In other words, Serevent and Foradil should not be used alone to treat asthma. Once asthma control is achieved, it is recommended to try to reduce medication. If asthma can be controlled with a low or medium dose of inhaled corticosteroids, then long-acting bronchodilators should be avoided.
    The safety of long-acting bronchodilators in adolescents has been questioned in the past. The FDA has recommended that products that contain long-acting bronchodilators such as Advair and Symbicort should be used in this age group because the ease of use has helped compliance. This results in improved symptom control and less risk of complications of uncontrolled asthma such as oral steroid use, ER visits and hospitalization.
    A recent study published in February of this year in the Journal of Allergy and Clinical Immunology performed an analysis of the use of formoterol (an ingredient in Foradil and Symbicort), in over 23,000 subjects. There was no evidence of an increased risk for serious events, including hospitalization and death in the formoterol group.
    We at the Allergy, Asthma & Sinus Care Center review the current safety data of all of the medications that we prescribe. We are often asked if it is necessary to use medications to treat asthma, and if the medications are safe. The “cure” for asthma has yet to be found, and every medication does carry at least some potential for side effects or risk. Overall, we feel that there is a place for medications such as Advair and Symbicort. These medications are a necessary tool in order to achieve control of asthma, but we do always look for opportunities to use less medication when possible.

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