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FDA Panel: Serevent & Foradil aren’t worth risk but backs Advair

A FDA Panel said Thursday that the risks of death and serious injury associated with two popular brands of asthma inhalers are greater than the benefits of the drugs. However, in what is sure to be a controversial opinion, said that Advair should continue to be used to treat asthma.


The panel of medical experts appointed by the FDA to advise the agency on certain drugs, however, stopped short of recommending that Serevent and Foradil not be used at all. Instead, the panel suggested the asthma drugs’ labeling be reworded to alert patients and health-care professionals about the risks. Serevent’s generic name is Salmeterol, Advair is a combination of Salmeterol and Fluticasone.


Asthma is a chronic condition which affects about 22 million Americans, including 6.5 million children and is marked by narrowing of the airways, which causes sudden difficulty breathing.


Serevent, made by GlaxoSmithKline PLC, and Foradil, made by Schering-Plough Corp., are inhalers known as long-acting beta-agonists, or LABAs. The drugs are designed to reduce tightening of the muscles around the airway caused by asthma.

The category of drugs has been prescribed to an estimated six million asthma patients who are unable to control asthma symptoms with other drugs, including inhaled corticosteroids. LABAs have been shown particularly effective at reducing airway swelling in these asthma patients.


The FDA asked the panel expert panel for advice on whether to allow certain drugs to continue to be marketed for the treatment of asthma in children and adults. There have been concerns that the products increase the risk of asthma-related side effects.


The FDA has previously said that Serevent, Foradil, and similar drugs are linked to an increased risk of asthma-related side effects, particularly in children and the elderly. The side effects have resulted in injuries including asthma-related death, hospitalization, and asthma-related intubations, where a tube must be placed in patients’ noses or mouths to help them breathe.


The agency found an additional 2.8 asthma events per 1,000 patients treated with a LABA compared with patients not receiving the drugs.


While the panel found the risks of Serevent and Foradil outweighed the benefits, other asthma drugs fared better. The panel said the same risks of asthma-related side effects and injuries were not seen with Advair, another top-selling Glaxo drug that uses the active ingredient in Serevent along with a corticosteroid. Advair has largely replaced Serevent as an asthma treatment.

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