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Allergists Respond to FDA Committee Recommendation on Asthma Medication, Encourage Patients with Questions to Contact Physicians

WASHINGTON--(BUSINESS WIRE)--Dec 11, 2008 - The nation's allergists urged a Joint FDA Advisory Committee today to continue to make long-acting beta-2 agonists available for the treatment of moderate-to-severe asthma in appropriate patients.

The Committee recommended the continued availability of long-acting beta-2 agonists Advair (fluticasone propionate and salmeterol) and Symbicort (budesonide/formoterol fumarate dihydrate) but said Serevent (salmeterol xinafoate) and Foradil (formoterol fumarate) should no longer be used for treating asthma.

The American College of Allergy, Asthma and Immunology (ACAAI) and the American Academy of Allergy, Asthma and Immunology (AAAAI) presented a statement supporting the efficacy and safety of long-acting beta-2 agonists when used as recommended. The medications are typically used in combination with inhaled corticosteroids. Advair and Symbicort are combination products containing both long-acting beta-2 agonists and inhaled corticosteroids.

“Long-acting beta-2 agonists play a very important role in managing and controlling asthma, particularly in patients with moderate-to-severe asthma, and the benefits of the medication often far outweigh the risks,” said ACAAI President Richard Gower, M.D. “The College is pleased to see that the Committee determined both Advair and Symbicort are effective and safe medications for the treatment of asthma for all previously approved age groups.”

The FDA Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee and Pediatric Advisory Committee met Dec. 10-11 to review the benefit/risk assessment of long-acting beta-2 agonists in adults and children. These medications have been under review since 2003 for potential risks including an association with an increased risk for life-threatening asthma attacks or death, particularly in African Americans.

The ACAAI and AAAAI based their recommendation on research that confirms the proper use of long-acting beta-2 agonists in combination with inhaled corticosteroids is safe and provides excellent long-term control of asthma. Discontinuing their use would set the safety and effectiveness of asthma treatment back 20 years to a time when potentially riskier medications were more commonly used, the allergists told the committee.

Recent guidelines from the National Heart, Lung and Blood Institute (NHLBI) on the diagnosis and treatment of asthma also support the appropriate use of these medications in patients 12 and older. The ACAAI and the NHLBI note the need for additional studies to determine the benefits of the medication in younger children and agree that the medications should not be used alone for asthma management in adults or children.

Until additional studies are conducted in children, the ACAAI recommended that the FDA follow the NHLBI guidelines which support the effectiveness of the medications as a supplemental therapy to inhaled corticosteroids.

“While it's important to be aware of the potential adverse effects of long-acting beta-2 agonists, there is no question that these medications are a beneficial treatment for asthma patients of all ages,” Dr. Gower said. “As with any medication, asthma patients concerned about their treatment should discuss options with a doctor before changing or stopping therapy.”

Additional information on asthma is available on the ACAAI Web site at

Contact: The American College of Allergy, Asthma and Immunology
Jo Ann Faber
(847) 427-1200 x240

Posted: December 2008