Using long-acting beta2-agonists safely: What will be the impact of the US Food and Drug Administration's panel recommendations?
The US Food and Drug Administration (FDA) has launched an investigation into the safety of long-acting beta(2)-agonists (LABAs). While the impact of this investigation is yet to be seen, clinicians should be circumspect in the use of these agents and prescribe them according to the recommendations of current asthma guidelines, informing patients and their caretakers about potential risks. As clinical trials attempt to address the question of whether LABAs are safe for use in pediatric and adult populations, current data provide no clear answers. A special hearing of the FDA's Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and Pediatric Advisory Committee attempted to seek consensus on the matter as it reviewed the results of controlled clinical trials and conducted a benefit:risk assessment of LABAs to make recommendations on their safety.
Smart
Brian A
BA
Asthma and Allergy Center, DuPage Medical Group, Glen Ellyn, Illinois 60l37, USA. brian.smart@dupagemd.com
D000318:Adrenergic beta-Agonists / Q000009:adverse effects* / Q000627:therapeutic use; D000367:Age Factors; D001249:Asthma / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D003692:Delayed-Action Preparations; D006801:Humans; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
D000318:Adrenergic beta-Agonists; D003692:Delayed-Action Preparations