Advair Diskus, Advair HFA, Brovana, Foradil, Serevent Diskus, and Symbicort Information

Advair Diskus, Advair HFA, Brovana, Foradil, Serevent Diskus, and Symbicort Information
(Long Acting Beta Agonists)

On November 18, 2005, FDA alerted health care professionals and patients that several long-acting bronchodilator medicines have 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.

On March 2, 2006, FDA approved new safety labeling and Medication Guides for patients for Serevent Diskus (salmeterol xinafoate) and Advair Diskus (fluticasone propionate; salmeterol xinafoate).  On June 19, 2006, FDA approved new safety labeling and a Medication Guide for patients for Foradil (formoterol fumarate), and also approved Advair HFA. Symbicort Inhalation Aerosol was approved on July 21, 2006.

March 5, 2008 Update: 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 (http://www.fda.gov/ohrms/dockets/ac/oc07.htm#pac [1]). 

In January, 2008 FDA requested manufacturers of Advair Diskus, Advair HFA, Brovana Inhalation Solution, Foradil Aerolizer, Perforomist Inhalation Solution, Serevent Diskus, and Symbicort Inhalation Aerosol 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.

Labels and Medication Guides

Advair Diskus Label  (updated 3/2/2006)
Advair Diskus Medication Guide for Patients 
 
Advair HFA Label  (6/8/2006)
Advair HFA Medication Guide for Patients
 
Brovana Label  (10/6/2006)
Brovana Medication Guide for Patients 
Foradil Aerolizer Label  (updated 6/19/2006)
Foradil Aerolizer Medication Guide for Patients
 
Serevent Diskus Label   (updated 3/2/2006)
Serevent Diskus Medication Guide for Patients 

Symbicort Inhalation Aerosol Label 
Symbicort Medication Guide for Patients 
Patient Information Sheets
Fluticasone propionate; Salmeterol xinafoate (marketed as Advair Diskus) [HTML] [PDF] (updated 5/15/2006)
Fluticasone propionate; Salmeterol xinafoate (marketed as Advair HFA) [HTML] [PDF] (posted 7/5/2006)
Formoterol fumarate (marketed as Foradil Aerolizer) [HTML] [PDF] (updated 7/5/2006)
Salmeterol xinafoate (marketed as Serevent Diskus) [HTML] [PDF] (updated 5/15/2006)
Other Information

Historical Information