The risks of two widely used asthma drugs outweigh their benefits for both children and adults, a U.S. Food and Drug Administration advisory panel said.
The health panel targeted Serevent and Foradil, made jointly by Novartis AG and Schering-Plough, for restrictions, but it excluded Advair, Glaxo’s biggest-selling drug in the class of medications known as long-acting beta-agonists. It also left alone a fourth such drug, AstraZeneca’s Symbicort.
The health experts did not say that the use of Serevent and Foradil should be abandoned altogether.
Instead, they said the medications’ labeling should be reworded to urge doctors to use the drugs along with an inhaled corticosteroid — as guidelines already recommend.
That may help explain why Advair and Symbicort were spared. Serevent contains just one active ingredient, salmeterol, while Foradil contains only formoterol.
Advair is a combination of both salmeterol and fluticasone (an inhaled corticosteroid), while Symbicort contains formoterol and another steroid (budesonide). All of these drugs relax airway muscles, letting asthma patients breathe more easily.
The controversy over these drugs has been going on for several years, with two FDA officials recently calling for banning the use of these drugs for anyone under 17.
The results of studies noting a rise in asthma-related deaths by people using the medications have already resulted in a black-box warning that use could “increase the risk of asthma-related death.”
Read more at Yahoo News