FDA Changes Rules on Asthma Drugs

(February 22, 2010) - The Food and Drug Administration (FDA) is issuing new rules for a class of asthma drugs. (Read about "Asthma") The new rules state that long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.

FDA says these new requirements are based on analyses of clinical trials showing that use of these long-acting medicines is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults and death in some patients with asthma. The drugs involved include the single agent products Serevent and Foradil and combination medications Advair and Symbicort that also contain inhaled corticosteroids. These medications improve a patient's ability to breathe freely and reduce the symptoms of asthma by relaxing muscles in the lung's airways.

"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," said Badrul Chowdhury, M.D., director of the Division of Pulmonary and Allergy Products in the FDA's Center for Drug Evaluation and Research.

"The risks of hospitalization and poor outcomes are of particular concern for children; parents need to know that their child with asthma should not be on a LABA alone," said Dianne Murphy, M.D., director of the FDA's Office of Pediatric Therapeutics.

LABAs are approved to treat both people with asthma or with chronic obstructive pulmonary disease. (Read about "Chronic Obstructive Pulmonary Disease") The new recommendations only apply to the use of LABAs in the treatment of asthma.