Symbicort, Dulera, Advair, and Breo to Treat Asthma

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 for Black 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.

A man talking to his doctor about his asthma

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Serevent and Foradil are long-acting beta-agonists (LABAs) used to treat moderate and severe asthma. LABAs are not adequate controller therapies by themselves 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) when a LABA is required. Dulera, Advair, Breo, and Symbicort contain both an inhaled steroid and a LABA.

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 healthcare provider. 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, do not stop taking your prescribed asthma medications until speaking with your healthcare provider. If you choose not to use a LABA as part of your asthma therapy, please inform your healthcare provider of this decision prior to you stopping your asthma medications.

See the FDA warning letters on medications containing LABAs.

3 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM. The salmeterol multicenter asthma research trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129(1):15-26. doi:10.1378/chest.129.1.15

  2. Morales DR. LABA monotherapy in asthma: an avoidable problem. Br J Gen Pract. 2013;63(617):627-8. doi: 10.3399/bjgp13X675250

  3. Bell AD, McIvor RA. The SMART study. Can Fam Physician. 2007;53(4):687–688.

By Daniel More, MD
Daniel More, MD, is a board-certified allergist and clinical immunologist. He is an assistant clinical professor at the University of California, San Francisco School of Medicine and currently practices at Central Coast Allergy and Asthma in Salinas, California.