Is Advair Safe?

In February 2010, the Food and Drug Administration (FDA) provided an additional warning about asthma medications containing long-acting beta-agonists (LABAs), such as Advair and Symbicort. LABAs have been available in the United States since the mid-1990's as a controller therapy for the management of asthma. As a result of various studies showing a possible association of the use of LABAs and worsening asthma symptoms (including death from asthma), the FDA has recommended against the use of LABAs for the treatment of asthma unless absolutely necessary.

Instead of the use of asthma medications containing LABAs, the FDA recommends the use of other medications, primarily inhaled corticosteroids, as controller medications for asthma. Other alternatives include leukotriene blockers such as montelukast (Singulair), omalizumab (Xolair) and theophylline. Asthma medications containing LABAs, including Advair, should only be used for people not controlled with other medications as mentioned above, or with frequent asthma exacerbations requiring emergency room visits, hospitalizations or the use of oral or injected corticosteroids to control.

As an asthma specialist, I'm surprised by the new FDA warning. There is no new data to support such a warning since the Black Box Warning previously given to LABA medications. The FDA refers to two studies in particular that showed that LABAs may increase asthma symptoms, including asthma death. The two studies in question include the Salmeterol Multicenter Asthma Research Trial (SMART) and the Serevent Nationwide Surveillance (SNS) study.

SMART was conducted in 1996, with salmeterol (a LABA) being given to over 13,000 people with asthma. Some of these people were taking other controller medications for asthma; others were only using salmeterol every day. While salmeterol was found to be safe overall, it appeared to result in more asthma attacks, hospitalizations and asthma deaths in African American people.

When the African American participants in the SMART study were closely evaluated, it was found that they had more severe asthma as a group, yet were less likely to be using inhaled steroids to control their asthma. When those African Americans who were using inhaled steroids were evaluated, those given salmeterol did not seem to have increased problems as a result of its use.

The SNS study compared the effects of twice-daily dosing of the LABA Serevent (salmeterol) to four-times-a-day salbutamol (a European version of albuterol) on asthma control in over 25,000 people with asthma. While there was a slightly higher rate of asthma deaths in the salmeterol group, this was more likely due purely to chance and was not outside the expected amount of deaths in a population this size with severe asthma. This study was published in 1993, with the results available to the FDA prior to LABAs being approved for use in the United States.

LABAs are a commonly used medication for the treatment of asthma over the past 15 or more years in the United States. Despite the above studies and the apparent concern by the FDA, the number of asthma deaths has been on the decline over the past 10 or more years. Should you take an asthma medication containing a LABA, such as Advair or Symbicort? Only you and your doctor can make this decision. However, if you are taking a LABA, it's a good idea to see your doctor to discuss the risks and benefits of these medications. It is very important to not stop taking any prescription medication, including LABAs, before communicating with your doctor.

Learn more about the risks and benefits of using Advair.

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