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ADVANCE Perspective: Respiratory Views

Patients; Doctors Weigh in On LABA Risk

Published December 11, 2008 11:20 AM by test test

 A panel of 30 medical and scientific Food and Drug Administration advisors plans to vote today on whether the safety risks posed by long acting beta agonists outweigh the benefits to respiratory patients. But professional and patient organizations across the country have already weighed in today in support of keeping the medications on the market.

"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 the prepared remarks of Stanley Szefler, MD, professor of pediatrics and pharmacology at National Jewish, who will represent the AAAAI and ACAAI before the FDA today.

LABAs have a favorable risk to benefit ratio. Patients experience better results with combined LABA with inhaled corticosteroid therapy, than high-dose inhaled corticosteroid use alone, according to an AAAAI statement.

"When prescribed and used as part of a comprehensive treatment plan, 12-hour bronchodilators have given back to patients the ability to work, climb stairs, attend school, sleep through the night, and compete in sports - without symptoms - things most others take for granted," said Nancy Sander, president and founder of Allergy & Asthma Network Mothers of Asthmatics, who will also testify.

Their remarks dovetail with the position held by the FDA office in charge of respiratory drugs, which maintains that the serious complications and risk of death shown in an FDA analysis of 110 clinical trials of three of the four LABAs on the market-GlaxoSmithKline's Serevent, AstraZeneca's Symbicort, and NovartisAG's Foradil- could be avoided through increased warnings and educational materials for doctors and their patients.

However, officials in the safety office have recommended that doctors no longer prescribe Serevent and Foradil to treat asthma, and that they reserve GlaxoSmithKline's Advair and Symbicort for treating patients 18 and older. Clinical trials comparing Advair to steroid treatment did not show a higher rate of serious complications.

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