FDA Mandates New Safety Controls for Long-Acting Beta Agonists

From MedscapeCME Clinical Briefs > FDA Approvals and Safety Changes for CME

News Author: Robert Lowes
CME Author: Yael Waknine

February 25, 2010 — The US Food and Drug Administration (FDA) announced on February 24 that manufacturers of long-acting beta agonists (LABAs) must now state on product labels that asthma patients must not take LABAs on a long-term basis unless their condition cannot be adequately controlled with other medications such as inhaled corticosteroids.

The labels also must state that the LABAs should never be used alone in the treatment of asthma in adults or children. Instead, they should be combined with an asthma "controller" medication.

Roughly 95% of asthma patients using a LABA receive it in combination with a corticosteroid in a single inhaled product such as Advair Diskus, Advair HFA, or Symbicort, according to the FDA.

Advair Diskus and Advair HFA both contain a LABA called salmeterol (Severent), and Symbicort contains the LABA formoterol (Foradil). These LABAs, along with arformoterol (Brovana), are also marketed as stand-alone medications.

Under the agency's new safety controls, LABA manufacturers must state on product labels that pediatric and adolescent patients who need a LABA in addition to a corticosteroid should be prescribed one of these combination products, as opposed to 2 separate drugs, to ensure medication compliance

Clinical Implications

Because of the increased risk for severe and potentially fatal exacerbations, patients with asthma must not take LABAs on a long-term basis unless their condition cannot be adequately controlled with other medications such as inhaled corticosteroids.
This limitation does not apply to patients receiving LABAs for chronic obstructive pulmonary disease.

LABAs should only be prescribed together with inhaled corticosteroids and other controller medications; pediatric and adolescent patients should receive a combination product to ensure compliance.
Treatment should be minimized to the shortest duration required to achieve control of asthma symptoms.

Clinical trial data have demonstrated that the addition of the LABA salmeterol to usual asthma therapy is linked to an increased risk for fatal asthma events. Salmeterol is linked to an increased risk for respiratory and asthma-related deaths relative to albuterol.
LABAs are associated with an increased risk for asthma-related death, intubation, and hospitalization, particularly in pediatric patients.