Asthma drugs get risk management program

A new risk management program has been instituted for the use of long-acting beta-agonists (LABAs) to treat asthma, the FDA announced last week.

The changes are based on an FDA analysis that found an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations and some deaths in patients on the drugs. LABAs are available in single-ingredient products (Serevent and Foradil) and combination products containing inhaled corticosteroids (Advair and Symbicort). LABAs are now contraindicated without the use of an asthma controller medication, such as an inhaled corticosteroid.

LABAs should only be used long term in patients whose asthma cannot be adequately controlled on asthma controller medications and for the shortest duration of time required to achieve control of asthma symptoms. If possible, the medications should be discontinued once asthma control is achieved, an FDA press release said. Pediatric and adolescent patients requiring LABA treatment should be prescribed a combination product containing both the LABA and an inhaled corticosteroid to improve compliance with both medications. The agency has also called for additional clinical trials.