Abstract

For several years, the long-acting β-agonist (LABA) medication class has been under intense scrutiny over safety concerns when used as monotherapy in patients with asthma. 1 Chowdhury B.A. Pan G.D. The FDA and safe use of long-acting beta-agonists in the treatment of asthma. N Engl J Med. 2010; 362: 1169-1171 Crossref PubMed Scopus (221) Google Scholar , 2 Smart B. Using long-acting β2-agonists safely: what will be the impact of the US Food and Drug Administration's panel recommendations?. Clin Cornerstone. 2009; 3: 40-44 Crossref Scopus (1) Google Scholar , 3 Rodrigo G.J. Moral V.P. Marcos L.G. et al. Safety of regular use of long-acting beta agonists as monotherapy or added to inhaled corticosteroids in asthma: a systematic review. Pulm Pharmacol Ther. 2009; 22: 9-19 Crossref PubMed Scopus (56) Google Scholar , 4 Levenson M. Long-acting beta-agonists and adverse asthma events meta-analysis: statistical briefing packing for joint meeting of the Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee and Pediatric Advisory Committee. http://www.fda.gov/ohrms/dockets/ac/cder08.html#PulmonaryAllergyDate: December 10-11, 2008 Google Scholar On December 11, 2008, the Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee concluded that the potential risks of salmeterol or formoterol as monotherapy for asthma outweigh benefits and that physicians should not prescribe LABAs as stand-alone treatment in asthma patients. 2 Smart B. Using long-acting β2-agonists safely: what will be the impact of the US Food and Drug Administration's panel recommendations?. Clin Cornerstone. 2009; 3: 40-44 Crossref Scopus (1) Google Scholar , 5 US Food and Drug AdministrationSummary minutes of the joint Pulmonary-Allergy Drugs Advisory Committee (PADAC) Drug Safety and Risk Management Advisory Committee (DSaRM), and Pediatric Advisory Committee (PAC) December 10–11, 2008. http://www.fda.gov/ohrms/dockets/ac/08/minutes/2008-4398m1-final.pdf Google Scholar Despite the consistent messages from the FDA and the 2007 national asthma treatment guidelines to avoid LABA monotherapy in asthma patients, surveys of physicians suggest these warnings have been inconsistently adopted in practice. 6 Karpel J.P. Peters J.I. Szema A.M. et al. Differences in physician's self-reported knowledge of, attitudes toward, and responses to the black box warning on long-acting β-agonists. Ann Allergy Asthma Immunol. 2009; 103: 304-310 Abstract Full Text Full Text PDF PubMed Scopus (15) Google Scholar , 7 Ko F. Chan A. Chan H.S. et al. Are Hong Kong doctors following the Global Initiative for Asthma guidelines: a questionnaire “Survey on Asthma Management”?. Hong Kong Med J. 2010; 16: 86-93 PubMed Google Scholar

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