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FDA calls for stronger warnings on asthma drugs
LOS ANGELES (Reuters) - 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 advisory 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 should only be used after other medicines fail to control asthma.
Shares of Glaxo fell 4 percent to close at $49.92 on the New York Stock Exchange, while shares of Novartis rose 0.6 percent to close at $54.19.
The FDA said that even though long-acting beta 2-adrenergic agonists decrease the frequency of asthma episodes, these medicines may make asthma episodes more severe when they occur.
GlaxoSmithKline, Europe's biggest drug maker, disagreed with the proposed 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 long-acting beta 2-adrenergic agonists, 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.
The new safety alert could have a material impact on profits at Glaxo, which relies on its asthma franchise for about 15 percent of total sales, Prudential Equity analyst Tim Anderson said in a report.
Schering-Plough Corp., which markets Foradil in the United States, said it is still discussing the proposed label changes with the FDA.
"Safety is the most important thing ... patients should be discussing this with their doctors," said Schering spokeswoman Mary-Fran Faraji.
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.
Worldwide sales of Advair totaled $4.5 billion last year, making it Glaxo's top-selling product. Serevent sales were $639 million in 2004, while sales of Foradil were $320 million.
(Additional reporting by Julie Steenhuysen in Chicago and Pete Harrison in London and Deena Beasley in Los Angeles)
LOS ANGELES (Reuters) - 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 advisory 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 should only be used after other medicines fail to control asthma.
Shares of Glaxo fell 4 percent to close at $49.92 on the New York Stock Exchange, while shares of Novartis rose 0.6 percent to close at $54.19.
The FDA said that even though long-acting beta 2-adrenergic agonists decrease the frequency of asthma episodes, these medicines may make asthma episodes more severe when they occur.
GlaxoSmithKline, Europe's biggest drug maker, disagreed with the proposed 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 long-acting beta 2-adrenergic agonists, 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.
The new safety alert could have a material impact on profits at Glaxo, which relies on its asthma franchise for about 15 percent of total sales, Prudential Equity analyst Tim Anderson said in a report.
Schering-Plough Corp., which markets Foradil in the United States, said it is still discussing the proposed label changes with the FDA.
"Safety is the most important thing ... patients should be discussing this with their doctors," said Schering spokeswoman Mary-Fran Faraji.
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.
Worldwide sales of Advair totaled $4.5 billion last year, making it Glaxo's top-selling product. Serevent sales were $639 million in 2004, while sales of Foradil were $320 million.
(Additional reporting by Julie Steenhuysen in Chicago and Pete Harrison in London and Deena Beasley in Los Angeles)