FDA considers ban of asthma drugs

January 23, 2009

The Food and Drug Administration is considering an advisory committee recommendation to ban the use of two drugs for asthma treatment in adults and children.

The Food and Drug Administration is considering an advisory committee recommendation to ban the use of salmeterol and formoterol monotherapy for asthma treatment in adults and children. The committee instead recommends that asthma be treated with products combining the long-acting beta agonists (LABAs) with a steroid.

Although current labeling warns of an increased risk of death while using either LABA alone, committee members told the FDA that too many physicians prescribe them for asthma without a steroid. Used alone, both drugs are also associated with worsened asthma attacks.

While physicians may prescribe a separate steroid along with the LABA, patients often stop using the steroid because the LABA is quick-acting and gives them a type of "rush," says Thomas Casale, MD, executive vice president of the American Academy of Allergy, Asthma and Immunology. Patients don't feel anything with a steroid, since it works over time to reduce inflammation, he says.

Salmeterol and formoterol inhalers are likely to remain on the market because of their efficacy in treating symptoms of chronic obstructive pulmonary disease.

-Heide Aungst, Senior Editor