Free Republic

The Food and Drug Administration is requiring major changes to the prescribing information of inhaled long-acting beta-agonists as part of a risk management plan to address the ongoing safety issues associated with the products' use in children and adults with asthma, the agency announced at a press briefing. Safety concerns regarding long-acting beta-agonist (LABA) therapy date back to a major study reported more than 7 years ago and include a 2008 FDA meta-analysis, which indicated that treatment with LABAs—either alone or when combined with an inhaled corticosteroid (ICS)—is associated with an increased risk of severe asthma symptoms and hospitalizations as...

ASSOCIATED PRESS WASHINGTON -- The Food and Drug Administration warned Friday that three asthma drugs may increase the risk of severe asthma attacks and even death. The agency asked the manufacturers of Advair, Serevent and Foradil to strengthen the warning labels to reflect this risk. The FDA said that even though the drugs decrease the frequency of asthma attacks, they can make the attacks more severe when they occur. The agency said the drugs should be prescribed only if other medicines do not control patients' asthma. Advair had sales of $4.7 billion in 2004, making it one of GlaxoSmithKline's top-selling...