The US Food and Drug Administration (FDA) has released final label revisions for respiratory medications used for the treatment of asthma that contain a long-acting beta-agonist (LABA). This follows the FDA’s February communication requesting all manufacturers of LABA-containing medications to undertake class-labeling changes.
The label revisions apply to both single ingredient and combination LABA-containing medications. The new recommendations in the updated label state:
- Use of a LABA alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated, or 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.
- LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid.
- Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step-down therapy should begin (eg, discontinue LABA), if possible without loss of asthma control, and the patients 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.
In addition, the boxed warning and other relevant sections of the label have been revised to inform health care professionals and patients that LABAs, when used as single ingredient products, increase the risk of asthma-related death based on a large placebo-controlled study with salmeterol (a single ingredient LABA product).