Risk Management Strategy Required for All Long-Acting Beta-Agonists

2/24/2010
The FDA is notifying health care providers and consumers that a risk management strategy (REMS) and class-labeling changes are being required for all long-acting beta agonists (LABAs) due to safety concerns. The REMS must include a revised patient Medication Guide and a strategy to educate health care professionals about appropriate LABA use. The FDA based these changes on study analyses that demonstrated an increased risk of severe exacerbation of asthma symptoms, resulting in hospitalizations in pediatric and adult patients, as well as possible fatalities, in some patients using LABAs for the treatment of asthma.  Although the FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication, health care providers should be aware that: single-ingredient LABAs should only be used in combination with an asthma controller medication; long-term LABA use should be reserved for patients whose asthma cannot be adequately controlled with asthma controller medications; LABAs should be used for the shortest duration required to achieve adequate asthma control and discontinued once control is achieved; and a combination inhaled corticosteroid/LABA product should be used when necessary to ensure compliance with both medications.     
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