FDA officials disagree on the safety of four of the most popular drugs used to treat asthma. On December 6, 2008, The New York Times reported that 2 federal drug officials wrote on the FDA's web site that asthma patients of all ages should not use four of the most popular asthma drugs—Advair, Symbicort, Serevent and Foradil. However, a third drug-safety official concluded that Advair and Symbicort were safe for use by adults but that all four drugs should not be used by patients age 17 or younger. While the director of the division of pulmonary and allergy products stated that the risk of death associated with the four drugs was small and that banning their use could cause asthmatics to rely on even riskier medications. Disagreement amongst agency experts was once unheard of but this is not the first time such disagreement has surfaced in recent years.

Asthma results when airways swell and spasm restricts the flow of air into and out of the lungs. The two primary treatments are steroids which reduce swelling, inflammation and mucous production and beta agonists (bronchodilators) that relax smooth muscle and treat spasms. Albuterol is a beta agonist used as a rescue medication because of its rapid onset of action. However, albuterol's effects are not very long-lasting. Albuterol appears to make patients’ lungs more sensitive to severe attacks. As a result asthmatics are advised to use their rescue inhalers only when needed to break an acute asthma attack. Long-acting beta agonists such as salmeterol in Serevent and formoterol in Foradil were introduced to control bronchospasms for long periods, reducing the need for rescue bronchodilators such as albuterol. Serevent was approved in 1994 and reports soon surfaced about asthma deaths. The manufacturer Glaxo warned patients that salmeterol does not work instantly like albuterol and it should not be used during an attack. Drug manufacturers say this risk is eliminated by adding a steroid to reduce inflammation. Advair combines salmeterol with the steroid fluticasone and Symbicort combines formoterol with the steroid budesonide.

Obviously, there is still disagreement whether there is increased risk of death from use of the inhalers or not. There is much at stake for drug manufacturers. Advair sales have approached $8 billion this year. Symbicort, introduced last year, had $209 million in sales in the first 9 months of this year. Safety studies of these drugs have been difficult to design and interpret. Treatment options for asthmatics are limited, as these drugs have dominated the market since their introduction.

For now, asthma patients should not change their treatment without discussing options with their doctors. The most likely treatment option is to use a steroid inhaler alone to control inflammation and swelling in airways and a short-acting bronchodilator like albuterol when needed to control an attack. But even then, increased use of short-acting bronchodilators is thought to increase the risk of severe, life-threatening asthma attacks. In addition, asthmatics should learn to use a peak flow meter to monitor for decreased air flow before an attack begins and they should keep an asthma diary to identify triggers of asthma attacks so that they may avoid triggers or increase the use of medications prior to exposure to triggers to limit an attack.

Reference: http://www.nytimes.com/2008/12/06/health/policy/06allergy.html.

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