Advair and Symbicort: “Benefits Outweigh Risk” says an FDA Advisory Committee

FDA Advisory Committee recommended using combination asthma drugs rather than long-acting bronchodilators alone for asthmatics, but they're OK for COPD Sufferers.

Last week the Food and Drug Administration (FDA) listened to presentations and comments from several members of an expert FDA advisory committee regarding the benefit-to-risk ratio of Long Acting Beta-agonist drugs (LABAs). The advisory panel consisted of 27 voting health care professionals representing subcommittees in pulmonary and allergy medicine, safety and risk, and pediatric advisory.

The medications of interest were LABAs prescribed for treatment of asthma which included Serevent (salmeterol), Foradil (formoterol), Advair (a combination of fluticasone and salmeterol) and Symbicort (a combination of budesonide and formoterol). Representatives from the pharmaceutical companies that make these drugs were invited to present all available clinical studies on effectiveness and adverse effects of their drug. The companies included GlaxoSmithKline, Astra Zeneca and Novartis.

In summary, the FDA advisory panel voted, unanimously, that the benefit of Advair and Symbicort outweighed the risks of adverse effects in adults. In older children (12-18 years) an overwhelming majority of panel members felt benefit outweighed risks for both of these inhalers. Advair is the only one of the two approved for use in the age 4-11 year range, and was voted for favorably by a narrow margin. Symbicort is approved only for adults and children 12 years and older. The concern with these inhalers does not stem from any new studies or reports of adverse events.

The FDA has two major concerns:

1) The isolated use of LABAs in asthma care. For example, a doctor prescribing Serevent or Foradil alone, for management of asthma (without an inhaled steroid/controller medication).

2) The use of LABAs in young children has not been as well studied in clinical trials (compared to older children and adults).

Why is the FDA concerned about Serevent and Foradil prescribed alone?

Long Acting Beta-Agonists have been a recurring media focus since 2003 when the SMART study (Salmeterol Multicenter Asthma Research Trial) was halted early as a result of a trend of worsening asthma and increased mortality (especially in African-Americans) was observed in patients on salmeterol compared to placebo. In addition it didn't appear that the target enrollment of 60,000 study patients was going to be reached. Since that time, a plethora of opinions have been published, many of which suggest results of the SMART study do not reflect the outcomes of studies with combination LABA/inhaled steroid inhalers. Dr. Fred Little posted his comments on formoterol and salmeterol recently.