- The Washington Times - Friday, January 24, 2003

WASHINGTON, Jan. 24 (UPI) — The Food and Drug Administration halted a large safety study of an approved asthma drug following indications it could increase the risk of death in some patients.

The study began in 1996 after FDA received reports of several deaths in asthma patients using the drug, Serevent Inhalation Aerosol. Serevent was approved in the United States in 1994 for treating asthma and later for the treatment of chronic obstructive pulmonary disease or COPD.

An interim analysis of the study by the drug's manufacturer, GlaxoSmithKline, "suggests that the drug may be associated with an increased risk of life-threatening asthma episodes or asthma-related deaths, particularly in some patients," FDA said in a written statement released Thursday.

"There was a trend … toward increases in asthma deaths and serious asthma episodes when all patients in the study were considered, though … this did not reach statistical significance," the agency said. The risk might be greater in African-Americans and those not using inhaled corticosteroids.

FDA noted, "The active drug in Serevent, salmeterol, is also contained in the asthma drugs Serevent Diskus and Advair Diskus, also manufactured by Glaxo."

The agency, however, stressed that patients should not stop taking Serevent or any other asthma or COPD medication without first consulting with their physician. "Abruptly stopping drugs for the treatment of asthma and COPD can result in serious exacerbations of these diseases that could be life-threatening," FDA said.

The agency said it soon will meet with Glaxo and "determine what steps are warranted to address this important new risk information."

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