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STUDY OF ASTHMA-DRUG HALTED

The Food and Drug Administration (FDA) today announced that an interim analysis of a large safety study of the approved asthma drug Serevent (salmeterol xinafoate) Inhalation Aerosol suggests that the drug may be associated with an increased risk of life-threatening asthma episodes or asthma-related deaths, particularly in some patients.

The interim analysis did not show a statistically significant result for the primary endpoint - a combination of respiratory-related deaths or intubations (or ventilatory failure). There was a trend, however, towards increases in asthma deaths and serious asthma episodes when all patients in the study were considered, though again this did not reach statistical significance. A further analysis of the data from the study suggested that the risk might be greater in African-American patients. Also, further analyses showed that patients not taking inhaled corticosteroids at study entry appeared to have greater risk for serious outcomes than those who were taking inhaled corticosteroids.

This study was designed to further investigate the safety of Serevent, particularly whether it might rarely cause serious asthma-related adverse events. It was begun in 1996, after FDA received post-marketing reports of several asthma deaths associated with the use of Serevent Inhalation Aerosol and following publication of studies raising concern about the regular use of short-acting and long-acting beta agonists, including Serevent. Because asthma patients can sometimes suffer sudden, serious life-threatening episodes of bronchospasm as a consequence of their disease, the deaths and serious adverse events reported for Serevent could neither be clearly attributed to use of this product, nor could it be excluded as a cause. This study was undertaken to try to help provide better information on the safety of this product.

Today, the manufacturer of Serevent Inhalation Aerosol, GlaxoSmithKline (GSK), notified investigators that it is stopping this study, mostly due to difficulties in enrollment and the likelihood the study would not give a clear result, even if fully enrolled. The Glaxo Data Safety Monitoring Board overseeing this trial conducted the interim data analyses that led to today's action. Approximately 26,000 subjects, representing more than 4.3 million patient-days of exposure to the drug, had participated in the study. The study was intended to enroll 60,000 patients.

FDA routinely monitors adverse event reports as part of its continuing efforts to reduce adverse events. Drug safety and risk management are among FDA Commissioner Dr. Mark B. McClellan's top priorities.

FDA approved Serevent Inhalation Aerosol in 1994 to treat asthma, and later this approval was extended to use for treatment of chronic obstructive pulmonary disease (COPD). The drug belongs to the class of asthma medications known as beta2-receptor agonists (commonly called beta agonists). The active drug in Serevent, salmeterol, is also contained in the asthma drugs Serevent Diskus and Advair Diskus, also manufactured by Glaxo.

FDA plans to meet with Glaxo shortly to obtain more details about the data from the interim analyses of the study and to determine what steps are warranted to address this important new risk information. FDA is particularly interested in further evaluating the question of whether certain patients may be at a greater risk for rare, but potentially serious adverse events due to Serevent use and use of other related drugs.

FDA emphasizes that based on available data, the benefits of Serevent for the asthma population continue to outweigh the risks and that the serious adverse events reported in the trial were rare. FDA strongly advises patients that they should NOT stop taking Serevent, or any other medication, for asthma or COPD, without first talking to their physicians. Abruptly stopping drugs for the treatment of asthma and COPD can result in serious exacerbations of these diseases that could be life-threatening. FDA further emphasizes that all asthma drugs, including Serevent, should be a given as a part of a comprehensive treatment plan that takes into account the patient's asthma severity and fully educates the patient in the disease and its proper treatment.

An estimated 16 million patients in the U.S. now have asthma, and the number of asthmatics has increased significantly in the recent decades. In addition to the beta2-receptor family of medications, other drugs approved for asthma include leukotriene blockers, inhaled corticosteroids and theophylline.

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