|This information has been updated. Please see Long-Acting Beta Agonist (LABA) Information.|
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 (budesonide; formoterol fumarate dihydrate) was approved on July 21, 2006. Perforomist Inhalation Solution (formoterol fumarate) was approved May 11, 2007.
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 (Pediatric Advisory Committee Information).
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 from Drugs@FDA (Medication Guides can be found at the bottom of the labels)
Long-Acting Beta Agonist (LABA) Information Serevent Diskus, Advair Diskus, and Foradil Information (Historical Information)[ARCHIVED] 2007 Meetings of the Pediatrics Advisory Committee to the FDA Information for Healthcare Professionals: Angiotensin-Converting Enzyme Inhibitor (ACE inhibitor) Drugs and Pregnancy[ARCHIVED]
Public Health Advisory: Update on Serevent Diskus (salmeterol xinafoate inhalation powder), Advair Diskus (fluticasone propionate & salmeterol inhalation powder), Foradil Aerolizer (formoterol fumarate inhalation powder)[ARCHIVED]
Labeling and Regulatory History from Drugs@FDA
Medication Guides can be found at the bottom of the labels)
Advair Diskus Prescribing and Label Information Advair HFA - Prescribing and Label Information Arformoterol tartrate (marketed as Brovana) Prescribing and Label Information Formoterol Furmate (marketed as Foradil) Prescribing and Label Information Formoterol Furmate (marketed as Performist) Prescribing and Label Information Salmeterol Xinafoate (marketed as Serevent) Prescribing and Label Information Budesonide and Formoterol Furmate (marketed as Symbicort) Prescribing and Label Information