Government health advisers recommended that the risks of two inhaler drugs outweigh their benefits and should no longer be used to treat asthma. The panel said two drugs Serevent and Foradil should not be prescribed by doctors to children or adults as a stand alone treatment for the disease.  The two more widely used drugs Advair and Symbicort are in a class of drugs known as beta-agonists and had benefits that clearly outweighed the risks as they contain a second ingredient that along with relaxing muscles around stressed airways reduces inflammation inside breathing passages and may help patients avoid such problems.

Daniel Notterman, MD, a member of the advisory panel from the department of molecular biology at Princeton University said, "I think the label should be greatly strengthened to say that monotherapy for asthma should basically be contraindicated" for Serevent and Foradil.

According to FDA analyses presented this week beta-agonists should ideally only be used in combination with inhaled steroids that cut down on airway inflammation leading to attacks as the combination lowers the risks. Studies show that many patients do not use inhaled steroids as directed when taking them separately from beta-agonists and can lead to many patients using the beta-agonist alone (called monotherapy), which raises the risk of dangerous side effects.

The panel of nearly 30 outside advisers voted 17-to-10 in agreement that the risks of long-term Serevent and Foradil use outweigh the benefits when used alone. The panel cast a similar vote for adolescents with asthma and voted unanimously that the drugs are not worth the risk in children 4 to 11 years old. The FDA usually follows the recommendations of its outside advisers. David Schoenfeld, PhD, a panelist and professor of medicine from Massachusetts General Hospital said, "The data is that single use is dangerous."

Ellen Strahlman, MD, the chief medical officer of GlaxoSmithKline, which makes both Advair and Serevent, said the company was pleased with the committee's backing of Advair but felt that the panel's vote to restrict Serevent could "deny patients needed treatment for optimal care of their asthma." Novartis and Schering-Plough issued a statement which said, "We believe this opinion is inconsistent with clinical evidence supporting the benefit/risk profile of Foradil in patients not adequately controlled on other asthma-controller treatments," the statement read.

John Jenkins, MD, who heads FDA's Office of New Drugs, said the FDA now has to go back and consider whether to change product labeling or indicated uses for Serevent and Foradil and it will also consider ordering new safety studies. He emphasized those patients currently taking Serevent or Foradil "should not stop taking your asthma medications without talking to your physician."