ASTHMA-RELATED DEATH: Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large, placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) to placebo added to patients' usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including olodaterol, one of the active ingredients in SPIOLTO RESPIMAT.
SPIOLTO RESPIMAT is only indicated for COPD. The safety and efficacy of SPIOLTO RESPIMAT in patients with asthma have not been established. SPIOLTO RESPIMAT is not indicated for the treatment of asthma.