Symbicort, Dulera, Advair, and Breo to Treat Asthma

A man talking to his doctor about his asthma.

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The U.S. Food and Drug Administration (FDA) has provided a warning to patients taking medications such as Dulera, Advair, Symbicort, Breo, Foradil, and Serevent. One study, the SMART trial, showed an increased risk of death from asthma and other respiratory problems when compared to ​placebo in patients taking Serevent, particularly in African-American patients. For this reason, the FDA has assigned a black-box warning for these medications, the highest level of warning for a medication that the FDA can give.

Serevent and Foradil are long-acting beta-agonists (LABAs) used in the treatment of moderate and severe asthma. LABAs are NOT adequate controller therapies by themselves for asthma, and can potentially cause life-threatening asthma attacks if used alone. A person with asthma, therefore, should always use an inhaled corticosteroid (such as Flovent, Pulmicort, QVAR) in the treatment of asthma when a LABA is required. Dulera, Advair, Breo, and Symbicort contain both an inhaled steroid and a LABA.

Unfortunately, the SMART trial did not address whether a particular patient was taking an inhaled corticosteroid for their asthma – this was completely a decision of the patient’s physician. Most of the patients with the most severe asthma were not taking an inhaled corticosteroid when placed on the LABA. When the study looked at the patients who were taking an inhaled corticosteroid and a LABA (such as Dulera, Advair, Symbicort and Breo contain), there did not appear to be an added risk of severe asthma attacks or death from asthma.

The FDA now states that a LABA medication should not be used if a person with asthma is controlled by an inhaled corticosteroid alone. If asthma is not controlled on an inhaled steroid, additional treatment choices include either increasing the dose of the inhaled corticosteroid (which may have its own risks) or the addition of other medications such as a LABA, Singulair, theophylline, oral prednisone and/or Xolair. Keep in mind that untreated asthma has its own risks as well, which can include severe, life-threatening asthma attacks.

For most people, the benefits of an inhaled corticosteroid and LABA medication (Dulera, Advair, Breo, and Symbicort) far outweigh the risks. However, it is important for you to know the risks and benefits of these medications so that you can make an informed choice. If you are already using a LABA medication as part of your asthma therapy and are concerned regarding the above information, please DO NOT stop taking your prescribed asthma medications until speaking with your doctor. If you choose not to use a LABA as part of your asthma therapy, please inform your doctor of this decision prior to you stopping your asthma medications.

See the FDA warning letters on medications containing LABAs.

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Article Sources

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  • Nelson HS. Long-Acting Beta-Agonists in Adult Asthma: Evidence that these Drugs are Safe. Primary Respiratory Care Journal. 2006;15:271-77.