Panel Critical of FDA's Asthma Drug Ruling
Experts Concerned About Limits on Long-Acting Asthma Drugs Such as Serevent and Foradil
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
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
"But the risk to a patients from LABAs is very remote," Busse tells
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
"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