ARTICLE | Regulation
The LABArinth of risk
December 15, 2008 8:00 AM UTC
A joint FDA advisory panel last week split the difference between the views of the agency's drug and safety sides on the use of long-acting beta-2 adrenergic agonists to treat asthma. Their recommendation is unlikely to have any practical impact, as doctors contacted by BioCentury say they don't prescribe LABAs by themselves anyway.
Based on an FDA meta-analysis showing an increased risk of asthma-related adverse events for LABAs used alone, but not for LABAs used with inhaled cortico-steroids (ICSs), FDA's Office of Surveillance and Epidemiology (OSE) took the position that the risk was too great to allow any product containing a LABA to be used for asthma...