LABAs Can Harm Asthma Patients When Used Alone

FDA warns of increased risk of severe worsening of asthma symptoms
By Andrea Mongler
HealthDay Reporter

THURSDAY, Feb. 18 (HealthDay News) -- The U.S. Food and Drug Administration has announced that long-acting beta agonists (LABAs) should never be used alone to treat asthma in children or adults.

The FDA made the announcement based on analyses of clinical trials showing that use of these medicines is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization and even death in some children and adults with asthma. The drugs involved in the warning include the single-agent products Serevent and Foradil, as well as Advair and Symbicort which also contain inhaled corticosteroids.

The FDA will now require manufacturers to provide a warning about this risk on product labels. Labels must now say that single-agent LABAs should be used only in combination with an asthma controller medication, not alone; that they should be used long term only in patients whose asthma cannot be controlled with asthma controller medications; and that they should be discontinued, if possible, once asthma control is achieved.

"Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death," Badrul Chowdhury, M.D., director of the Division of Pulmonary and Allergy Products at the FDA's Center for Drug Evaluation and Research in Silver Spring, Md., said in a Feb. 18 press release.

Press Release

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