About 20 million people in the United States suffer from asthma. Food and Drug Administration panel gave a clean chit to Advair and Symbicort (which combine a LABA and an inhaled steroid) but it added that the use of Serevent and Foradil could be risky.
FDA found 2.8 more serious asthma-related complications, including deaths and hospitalizations, for every 1,000 patients treated with a LABA.
Panel said that taking a LABA alone, without an inhaled steroid, seems to increase the risk of death and serious asthma attacks in some patients.
Consumer advocate Sidney Wolfe, director of Public Citizen's Health Research Group said: "It looks like use of LABAs alone is more dangerous,"
FDA officials have contrasting views regarding the plan of action. Drug-safety reviewers say that the asthma approval for all of the medicines in children should be withdrawn while experts in another division say that this step would be extreme because reviews of asthma drugs said the numbers of deaths and serious complications were small and risks were manageable with appropriate warnings.
Dr. Fernando Martinez, director of the Arizona Respiratory Center at the University of Arizona said: "There is no doubt the advent of long-acting beta agonists has improved the lives of the majority of patients ... it would be in my opinion irresponsible to withdraw this medicine."
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