National Jewish Physician Supports Access to Long-Acting Beta Agonists

Asthma Expert Addresses FDA on Behalf of American Academy of Allergy Asthma & Immunology and American College of Allergy Asthma & Immunology

Limiting the availability of medications known as long-acting beta agonists(LABA) would set asthma care back 20 years and increase risks of more asthma attacks, neurological adverse effects, growth and adrenal suppression, osteoporosis and cataracts, according to National Jewish Professor of Pediatrics and Pharmacology Stanley Szefler, MD. Dr. Szefler Thursday addressed a joint meeting of FDA committees considering reduced access to the medications. He spoke on behalf of two major physician organizations involved in asthma care: the American Academy of Allergy Asthma & Immunology and the American College of Allergy Asthma & Immunology.

"Based on many studies and patient outcomes, there is no question that LABA is a most beneficial treatment option for asthma patients of all ages," wrote Dr. Szefler in a prepared statement. (Dr. Szefler's actual remarks to the FDA may not exactly match the prepared testimony, but do accurately reflect his position.) "The risk-to-benefit ratio clearly favors their use."

LABA help relax constricted muscles in the airways of asthma patients. They are used as a supplement to inhaled corticosteroids, which reduce inflammation within the airways. LABA are sold as Serevent and Foradil. Advair and Symbicort contain both corticosteroids and LABA. The FDA committees met to address a longstanding controversy about the possibility of increased deaths among asthma patients who use LABA.

Dr. Szefler spoke out strongly in favor of LABA. He said that LABA, in conjunction with other medications and asthma guidelines, had helped move asthma care from a reactive therapy to a preventive one aimed at maintaining control of asthma. Their introduction had helped reduce high doses of corticosteroids given to patients, thus reducing the potential for side effects such as growth and adrenal suppression, osteoporosis, skin atrophy and cataracts. LABA had also helped end common use of theophylline, which carries risk of neurological side effects.

Dr. Szefler noted that the introduction of LABA had coincided with a reduction in asthma mortality nationwide, a plateau in asthma hospitalizations, and a marked reduction in the number of severe asthmatics requiring maintenance oral steroid therapy.

"A step to reduce the availability of LABA as a supplementary therapy for asthma management in children and adults would limit therapeutic options to those with less efficacy or more significant adverse effects," wrote Szefler. "In effect this would move asthma care back to a state of management we witnessed over 20 years ago that was fraught with serious neurological adverse effects related to theophylline and.. would lead to more exacerbations and thus prompt dependence on rescue oral steroid therapy also associated with severe adverse effects."

Dr. Szefler did note that there are little data on the effectiveness and safety of LABAs in children under five. He also said that LABAs should be used only in combination with corticosteroids.

Dr. Szefler was a member of the National Institutes of Health expert panel that recently published asthma treatment guidelines. They called for consideration of LABA for patients whose asthma remains inadequately controlled on low-dose inhaled corticosteroids.

"I urge you to trust that the expert panel has done due diligence in reviewing all treatment options and continue to support the availability of these valuable agents to better manage our patients with asthma," wrote Dr. Szefler.