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An FDA advisory panel has warned against continued use of salmeterol and formoterol for adults, adolescents and children with asthma. This is in view of the evidence for an increased risk of asthma-related deaths and serious complications in these groups. It is not known for certain whether the FDA will revoke the licences for LABA-only inhalers in asthma, although they usually follow the advice of their expert advisory panels.
Action
Prescribers are reminded to continue to use LABAs only in conjunction with inhaled corticosteroids (ICSs) (Step 3) in accordance with the British Guidelines for the Management of Asthma. A review of the safety of long-acting beta-agonists is currently being undertaken by the MHRA, and to ensure safe use, the CHM has advised how they should be used in the interim for the management of chronic asthma.
Background
In January 2008, the US Food and Drugs Administration (FDA) asked manufacturers of products containing long-acting beta-agonists (LABAs) to provide information regarding controlled clinical studies conducted with these products, in order to further evaluate their safety when treating asthma. The FDA conducted a meta-analysis of the clinical studies, the output of which was provided in a briefing document to an advisory panel meeting held to consider the safety of LABAs on 10th and 11th December 2008. Overall, the meta-analysis showed that LABAs were associated with an increased risk of asthma-related events relative to non-LABA treatment, as measured by the asthma composite endpoint consisting of asthma-related death, asthma-related intubation, and asthma-related hospitalisation. Non-LABA treatment included inhaled corticosteroids (ICS), short-acting beta-agonists, other non-LABA treatments, placebo, or a combination of treatments. The risk difference estimate for the asthma composite endpoint of the LABA rate minus the non-LABA rate was 2.80 events (95% CI 1.11 to 4.49) per 1000 subjects.
Outcome of the advisory panel meeting
A media report indicates that evidence of asthma-related deaths and serious complications led the panel of experts to warn against continued use of salmeterol and formoterol for adults, adolescents and children with asthma. The panel felt that there were less risks associated with the use of LABAs when used in combination with ICSs. When this is advice is considered by the FDA, they may decide to revoke the licences for LABA-only inhalers in asthma. Although this is not certain, they usually follow the advice of their expert advisory panels.
So what?
A review of the safety of long-acting beta-agonists is currently being undertaken by the MHRA, and to ensure safe use, the CHM has advised how they should be used in the interim for the management of chronic asthma. We considered the safety of long-acting beta agonists in an earlier blog, highlighting the need to use them only in conjunction with ICSs (Step 3) in accordance with the British Guidelines for the Management of Asthma.
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