FDA label changes for long-acting beta agonists may have unintended consequences

The FDA’s decision to change the labels on certain long-acting beta agonists to eliminate them as soon as asthma control is achieved may have some unintended consequences, like loss of asthma control and confusion for physicians, according to several speakers at the 2010 Annual Meeting of the American Academy of Allergy, Asthma and Immunology Meeting.

“The step-down process [in treatment of asthma with combination therapy] has not been well worked out … and withdrawing a medication that provides protection for individuals without good literature experience is an area where we all have concerns,”said William W. Busse, MD, of the University of Wisconsin. Busse, who served as chair of the third expert panel that developed the Guidelines for the Diagnosis and Management of Asthma, said that the panel agrees with the FDA that LABAs should not be the sole therapy for people with persistent asthma.

But Paul A. Greenberger, MD, immediate past president of AAAAI and professor in the division of allergy and immunology at Northwestern University, said there is disagreement over the studies the FDA cites as reasons for changing the LABA recommendations. He said he is concerned that the FDA’s recommendations have the potential to erect barriers that may lead to loss of asthma control.

Both Busse and Greenberger said the third panel recommendations discuss a step-down approach to asthma control, but those recommendations advocate waiting three months after establishing asthma control before considering stepping down treatment. Both panelists expressed concerns that the FDA’s new recommendations may lead to physicians prematurely pulling LABAs from patients who need them, which could result in return of symptoms or gradual exacerbation that patients may not immediately recognize.

Robert F. Lemanske, Jr., MD, head of the division of pediatric allergy, immunology and rheumatology at the University of Wisconsin School of Medicine and Public Health, expressed concern about how the changes might affect treatment options for children who have asthma.

“The FDA came out years ago with class-labeling for inhaled corticosteroids saying that they could potentially affect children’s growth, and this is much truer at higher doses, so that’s why if you start limiting our choices about being able to go to those high doses, it’s just going to be a problem,” Lemanske told Infectious Diseases in Children.

Other implications of the FDA’s label changes involve the possible increased use of inhaled corticosteroids for both children and adults.

The panel members encouraged extensive communication between patients and physicians to ensure that informed decisions are made. — by Melissa Foster