From Our 2010 Archives

Panel Critical of FDA's Asthma Drug Ruling

Experts Concerned About Limits on Long-Acting Asthma Drugs Such as Serevent and Foradil

By Charlene Laino
WebMD Health News

Reviewed By Louise Chang, MD

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.

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."

Robert Lemanske, Jr., MD, head of the division of pediatric allergy, immunology, and rheumatology at the University of Wisconsin School of Medicine and Public Health in Madison, tells WebMD that he is concerned that the FDA ruling will result in kids taking higher doses of inhaled steroids than necessary.

"As a pediatrician, anything I can do to limit doses of inhaled steroids, which can cause problems with growth, is very very important," he says.

Studies show that by adding a LABA, you can lower the dose of inhaled steroid by about 50%, Lemanske says.

Most importantly, the panel agrees, no one -- adults and kids alike -- should stop taking a LABA without consulting their doctor. That, they say, can be deadly.

No one exactly knows when LABAs can be discontinued, Busse says, "But you don't just turn them off as soon as you achieve control."

Inhaled steroids, the mainstay of asthma treatment, reduce airway inflammation and mucus production, leading to better asthma control, fewer symptoms and flare-ups, and reduced hospitalizations. But they do not relieve asthma symptoms you already have.

LABAs relax muscles in the lung's airways, improving a patient's ability to breathe freely and reducing asthma symptoms.

LABAs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations only apply to the use of LABAs in the treatment of asthma.

The panel says it hopes to perform further studies to better define if and when LABAs can be discontinued. And the FDA is requiring LABA makers to perform additional studies of the drugs' safety.

SOURCES: American Academy of Allergy, Asthma & Immunology Annual Meeting 2010, New Orleans, Feb. 26-March 2, 2010.

William Busse, MD, chair, department of medicine, University of Wisconsin School of Medicine and Public Health, Madison.

Stanley Szefler, MD, head of pediatric clinical pharmacology, National Jewish Health, Denver.

Robert Lemanske, Jr., MD, head, division of pediatric allergy, immunology, and rheumatology, University of Wisconsin School of Medicine and Public Health, Madison.

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