If you use Advair Diskus and are experiencing asthma symptons please read.

Over the past few years the FDA has sent out more than one Public Health Alert on the Advair Diskus, manufactured by GlaxoSmithKline. Advair, used for treatment of asthma and chronic obstructive pulmonary disease (COPD), has been linked with worsening asthma symptoms and increased risk of asthma-related death.

On November 18, 2005, FDA alerted health care professionals and patients that Advair had been associated with possible increased risk of worsening wheezing (bronchospasm) in some people, and requested that manufacturers update warnings in their existing product labeling. This information has now been included in updated labeling.

The most recent update, on March 5, 2008 stated: On November 28, 2007, a Pediatric Advisory Committee (PAC) meeting was held. At this meeting, FDA raised concerns about the safety of long-acting beta2 adrenergic agonists (LABAs) in pediatric patients with asthma. The PAC has agreed with an FDA recommendation to continue assessment of the risks of LABAs and seek advice from a future advisory committee.

In January, 2008 FDA requested manufacturers of Advair Diskus and Advair HFA to provide information regarding controlled clinical studies conducted with these products in order to further evaluate the safety of LABAs when treating asthma.

The manufacturers have indicated it will take several months to submit the requested information. Following review of this information, FDA plans to bring the issue of the benefit/risk assessment of LABAs in adults and children to an advisory committee in the fall or winter of 2008.