The US Food and Drug Administration (FDA) has announced a new requirement for product labeling to warn that long-acting beta-agonists (LABAs) should not be used alone for the treatment of asthma in children or adults, only in combination with a corticosteroid. The new requirements are based on FDA analyses of clinical trials showing that use of long-acting medicines is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization and death.
“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, MD, director of the Division of Pulmonary and Allergy Products in the FDA’s Center for Drug Evaluation and Research.
The drugs involved include the single agent products Serevent and Foradil and combination medications Advair and Symbicort, which also contain inhaled corticosteroids.
The Salmeterol Multicenter Asthma Research Trial first raised concerns over the use of LABAs as a monotherapy in 1996. The trial showed a possible increase in respiratory and asthma-related deaths in African Americans. The FDA continued to support the use of LABAs, but with the addition of a warning on the product label. Further reviews, however, found a significant increase in the risk of a serious worsening of asthma leading to death and hospitalization for patients treated with LABAs alone.
Source: PR Newswire