Long-acting β2 agonists and paediatric asthma

The US Food and Drug Administration's (FDA) Pulmonary and Allergy Drugs Advisory Committee recently strengthened the warning on all long-acting β2 agonists. 1 Chowdhury BA Division Director Memorandum: overview of FDA background materials prepared for the meeting to discuss the implications of the available date related to the safety of long-acting beta-agonist bronchodilators. http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4148B1_03_01-FDA-Div-Dir-Memo.pdfDate: June 15, 2005 Google Scholar This action was based on a number of pharmaceutical company initiated post marketing studies including the SMART study 1 Chowdhury BA Division Director Memorandum: overview of FDA background materials prepared for the meeting to discuss the implications of the available date related to the safety of long-acting beta-agonist bronchodilators. http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4148B1_03_01-FDA-Div-Dir-Memo.pdfDate: June 15, 2005 Google Scholar , 2 The FDA safety information and adverse event reporting program2003 Safety Alert – Serevent (salmeterol xinofoate). http://www.fda.gov/medwatch/SAFETY/2003/serevent.htm Google Scholar in adults showing a 1·71 (95% CI 1·01–2·89) total relative risk of asthma death or life-threatening experience with use of salmeterol compared with placebo. This RR rose to 4·9 (95% CI 1·68–14·45) in African-Americans. 1 Chowdhury BA Division Director Memorandum: overview of FDA background materials prepared for the meeting to discuss the implications of the available date related to the safety of long-acting beta-agonist bronchodilators. http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4148B1_03_01-FDA-Div-Dir-Memo.pdfDate: June 15, 2005 Google Scholar , 2 The FDA safety information and adverse event reporting program2003 Safety Alert – Serevent (salmeterol xinofoate). http://www.fda.gov/medwatch/SAFETY/2003/serevent.htm Google Scholar SMART is the only study powered for such outcomes, although smaller studies have reported the same increase in exacerbation rates in children and adults. 4 Bisgaard H Effect of long-acting β2-agonists on exacerbation rates of asthma in children. Pediatr Pulmonol. 2003; 36: 391-398 Crossref PubMed Scopus (100) Google Scholar , 5 Mann M Chowdhury B Sullivan E et al. Serious asthma exacerbations in asthmatics treated with high-dose formoterol. Chest. 2003; 124: 70-74 Crossref PubMed Scopus (159) Google Scholar The Canadian health body also warns of the possible increased risk of asthma-related deaths associated with the use of long-acting β2 agonists. We are still waiting for a reaction from the European Medicines Agency (EMEA).