Panel Critical of FDA's Asthma Drug Ruling
March 1, 2010 (New Orleans) -- A leading panel of asthma experts today criticized a new FDA ruling that long-acting asthma drugs should be used only for the shortest period of time required to achieve control of asthma symptoms and then discontinued.
The panel agreed with the FDA warning that the long-acting drugs Serevent and Foradil should never be used alone, but rather in combination with other asthma-control medications called inhaled steroids.
But the move to limit use of Serevent and Foradil as well as the combination drugs Advair and Symbicort puts patients at risk of full-blown, deadly asthma attacks, says William Busse, MD, chair of the department of medicine at the University of Wisconsin School of Medicine and Public Health in Madison.
All of the drugs are a member of a class of drugs called long-acting beta agonists (LABAs), which the FDA cautions can provoke a sudden, fatal asthma attack.
"But the risk to a patients from LABAs is very remote," Busse tells WebMD.
The risk of having a deadly attack if you suddenly stop taking the LABA medication once control is achieved is much greater, he says.
Busse was chair of the panel that wrote the asthma bible that most doctors follow -- the 2007 National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and
Management of Asthma.
"The fact that the [FDA ruling] runs counter to the asthma guidelines without any new information being introduced is of real concern," he says.
The experts addressed the issue during a special news briefing at the annual meeting of the American Academy of Allergy, Asthma & Immunology.
Since combination treatment with LABAs and inhaled steroids was introduced, the number of asthma attacks and hospitalizations has dropped, Busse says. "The longer a patient stays on treatment, particularly combination treatment, the better the control of asthma."
Stanley Szefler, MD, head of pediatric clinical pharmacology at National Jewish Health in Denver, says the FDA is relying on "studies done 10 years ago that are not in line with how we currently use the medications."
The panel agreed with the FDA warning that the long-acting drugs Serevent and Foradil should never be used alone, but rather in combination with other asthma-control medications called inhaled steroids.
But the move to limit use of Serevent and Foradil as well as the combination drugs Advair and Symbicort puts patients at risk of full-blown, deadly asthma attacks, says William Busse, MD, chair of the department of medicine at the University of Wisconsin School of Medicine and Public Health in Madison.
All of the drugs are a member of a class of drugs called long-acting beta agonists (LABAs), which the FDA cautions can provoke a sudden, fatal asthma attack.
"But the risk to a patients from LABAs is very remote," Busse tells WebMD.
The risk of having a deadly attack if you suddenly stop taking the LABA medication once control is achieved is much greater, he says.
Busse was chair of the panel that wrote the asthma bible that most doctors follow -- the 2007 National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and
Management of Asthma.
"The fact that the [FDA ruling] runs counter to the asthma guidelines without any new information being introduced is of real concern," he says.
The experts addressed the issue during a special news briefing at the annual meeting of the American Academy of Allergy, Asthma & Immunology.
Asthma Attacks Down Since LABAs Introduced
Since combination treatment with LABAs and inhaled steroids was introduced, the number of asthma attacks and hospitalizations has dropped, Busse says. "The longer a patient stays on treatment, particularly combination treatment, the better the control of asthma."
Stanley Szefler, MD, head of pediatric clinical pharmacology at National Jewish Health in Denver, says the FDA is relying on "studies done 10 years ago that are not in line with how we currently use the medications."