According to an FDA news release on 2/18/10, "These changes are based on FDA's analysis of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for treatment of asthma."
The FDA recommends that LABAs be used in combination with an asthma controller medication; LABAs that are single-ingredient should not be used alone; LABAs should only be used long-term in patients whose asthma is not controlled on asthma controller medications; LABAs should be used for the shortest time possible to gain control of asthma symptoms, at which point the LABA should be discontinued if possible; and children who use a LABA should use a combination product that contains an inhaled corticosteroid and a LABA.
The FDA also now requires a Risk Evaluation and Mitigation Strategy (REMS) for LABAs that will include a revised patient Medication Guide and has told manufacturers that additional clinical trials must be held to evaluate the safety of LABAs.
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Mintz says that what makes these recommendations dangerous is that some patients will simply stop taking their medications and will suffer because of it, potentially causing more harm than the LABAs themselves. Mintz notes that the FDA's own advisory committee voted 27 to 0 that Advair was safe but the FDA still went ahead with its new safety requirements.