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FDA calls for stronger warnings on asthma drugs

Sat Nov 19, 2005

CHICAGO (Reuters) - U.S. regulators on Friday asked the makers of three popular asthma medications to add new warnings to their labels stating that the drugs could increase the chances of severe asthma episodes that could result in death.

The warnings involve long-acting bronchodilator medicines Advair and Serevent, made by GlaxoSmithKline , and Foradil from Novartis AG . Patients use them daily to relax bronchial muscles and prevent asthma attacks.

In a public health warning issued on its Web site, the U.S. Food and Drug Administration said drugs in the class known as long-acting beta 2-adrenergic agonists (LABAs) should only be used after other medicines fail to control asthma.

GlaxoSmithKline, Europe's biggest drug maker, disagreed with the labeling changes, saying they were inconsistent with the standard of care for asthma treatment, which could put many patients at risk of uncontrolled asthma.

Guidelines from the National Institutes of Health currently recommend steroids and LABAs as initial therapy for moderate to severe persistent asthma.

"These proposed labeling changes would reserve the most effective asthma treatment -- the combination of inhaled corticosteroids and long-acting beta agonists -- until after a patient has failed on other treatment options and, therefore, may be at risk for severe outcomes, such as exacerbations and potentially death," Glaxo said in a statement.

Asthma is a chronic lung disease that afflicts about 15 million Americans, nearly 5 million of them children. The disease can cause episodes of wheezing, coughing and breathing difficulty. Severe asthma attacks can kill.

In July, an advisory panel to the FDA said the three asthma drugs were safe enough to stay on the market.

Glaxo's Serevent and Advair already come with "black box" warnings related to one study showing Serevent patients had a higher, albeit small, risk of life-threatening asthma attacks and deaths.

The panel urged that Novartis' medicine Foradil, part of the same class of drugs, should carry a similar warning.

(Reporting by Julie Steenhuysen in Chicago. Additional reporting by Pete Harrison in London and Deena Beasley in Los Angeles)


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