Symbicort, Dulera, Advair and Breo To Treat Asthma

Are Symbicort, Dulera, Advair and Breo Safe for the Treatment of Asthma?

Advair Diskus for the treatment of asthma. Daniel More, MD

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 on an inhaled corticosteroid alone. If asthma is not controlled on an inhaled steroid, additional treatment choices include (a) increasing the dose of the inhaled corticosteroid (which may have its own risks) or (b) 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 a 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.

Want to keep learning? Find out more about the treatments for asthma.

Sources:

Aaronson DW. The “Black Box” Warning and Allergy Drugs. J Allergy Clin Immunol. 2006;117:40-4.Nelson HS, Weiss ST, Bleeker ER, et al.

The Salmeterol Multicenter Asthma Research Trial. Chest. 2006;129:15-26.

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

DISCLAIMER: The information contained in this site is for educational purposes only, and should not be used as a substitute for personal care by a licensed physician. Please see your physician for diagnosis and treatment of any concerning symptoms or medical condition.

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