The US Food and Drug Administration Health Alert on Long-acting Beta-agonists: Is It Evidence Based or Biased?

摘要

The US Food and Drug Administration has recently issued a boxed warning on long-acting β2-agonists (LABAs) that these drugs can increase the risk of severe asthma-related adverse events including deaths. This action was prompted by the findings of the Salmeterol Multi-center Asthma Research Trial which revealed the use of salmeterol was associated with a >4-fold increased risk in the incidence of asthma-related deaths when compared with a matched-placebo over a 28-week unsupervised treatment period. However, this increased risk was only seen in patients who didn't take inhaled corticosteroids (ICS) at entry to the study. Other pharmaco-epidemiologic, case-controlled and clinical studies, however, have failed to demonstrate any significant association between LABAs and asthma-related deaths. It is likely that while unsupervised use of LABAs in patients who are not treated with ICS, especially when their disease is not well controlled, may potentially be detrimental and therefore should not be recommended, the combined use of this class of drugs with ICS is safe and effective.