Washington – The US Food and Drug Administration (FDA) has announced that long-acting beta agonists (LABAs) should never be used as monotherapy in the treatment of asthma. This class of medications is, in asthma, only to be prescribed together with inhaled corticosteroids or other controller drugs such as leukotriene antagonists.

The FDA not only warns of the dangers of monotherapy but also restricts the duration of treatment for this class of drugs: LABAs should only be used long-term in patients whose asthma cannot be adequately controlled with asthma controller medications. In addition, the FDA states that LABAs are only to be prescribed for the shortest duration necessary for achieving asthma control. Patients should then be maintained on an asthma controller medication.

Current guidelines already recommend combining LABAs with either an inhaled corticosteroid or a leukotriene antagonist. Most asthma patients receive LABAs long-term, in the form of combination medications that also contain inhaled corticosteroids.

This practice may be about to change in the light of the FDA announcement. The drugs concerned are salmeterol and formoterol.

These new requirements are based on FDA analyses of two large clinical trials, SMART and SNS, and a meta-analysis carried out in 2008, which together showed that use of these long-acting medicines is associated with an increased risk of severe worsening of asthma symptoms leading to hospitalisation in both children and adults and death in some patients with asthma.

“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, hospitalisations and death,” says Dr Badrul Chowdhury, director of the Division of Pulmonary and Allergy Products in the FDA’s Center for Drug Evaluation and Research.

Source:
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm199565.htm