The U.S. Food and Drug Administration requested today that the manufactures of Advair, Serevent and Foradil, inhalants prescribed for the relief of asthma, update their existing product labels with new warnings and a Medication Guide. The FDA made this request after an increased number of people taking these medications as part of clinical trials in addition to their usual asthma care died from their asthma compared to people taking a placebo.

Advair, Serevent and Foradil belong to a class of medications known as "long-acting beta 2-adrenergic agonists" or LABAs. These long-acting bronchodilator medicines help to relax the muscles around the airways in the lungs, preventing bronchospasm, or wheezing, from happening. Even though LABAs decrease the frequency of asthma episodes, which are marked by sudden tightening of the muscles around the airways, they may make the episodes more severe when they do occur.

Among the recommendations the FDA made today were guidelines for patients taking LABAs:

• LABAs should not be the first medicine used to treat asthma, but should only be added to asthma treatment plans only if other medicines do not control asthma
• Do not stop using your LABA or other asthma medicines that your health care professional has prescribed for you without discussing it with him or her first
• Do not use your LABA to treat wheezing that is growing worse. If your wheezing worsens while using a LABA, call your health care professional or an emergency service facility right away.
• LABAs should not be used to relieve sudden wheezing. Always have a short acting bronchodilator medicine with you to treat sudden wheezing.

Source: FDA Release, November 18, 2005.