Abstract
Two very large randomised trials (including over 50,000 participants) found an increase in asthma-related deaths in adults who were given regular salmeterol. Furthermore, individual patient data submitted to the FDA showed that the risks of serious adverse events while on regular formoterol or salmeterol were largest in the younger age-groups. This age-related trend was significant when regular formoterol or salmeterol were used with background inhaled corticosteroids (ICS), but was not found with combination inhalers. There are six separate Cochrane reviews looking at the safety of regular salmeterol or regular formoterol (with or without combination inhaled corticosteroids), and we have drawn data together into an overview of Cochrane reviews to summarise data on the serious adverse events in children from the randomised trials in all these reviews. We looked at children who suffered fatal and non-fatal (usually involving admission to hospital) serious adverse events of any cause, and also those related to asthma.
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