FDA has released final label revisions for respiratory medications that contain an active ingredient known as a long-acting beta-agonist (LABA). However, the new recommendations do not apply to the use of LABAs for the treatment of COPD.
Recently, FDA requested manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma.
The new recommendations for the updated labels state: use of a LABA alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (absolutely advised against) in the treatment of asthma.
LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.
Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure adherence with both medications.
FDA added that when LABAs are used according to the recommendations and in the approved drug labels, the benefits of LABAs in improving asthma symptoms outweigh their risks of increasing severe asthma exacerbations and deaths from asthma.