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New Safe Use Requirements: Using LABAs for Asthma Treatment

On February 18, 2010, the FDA issued updated recommendations governing the use of long-acting beta-agonists (LABAs) in the treatment of asthma. These changes are based on studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients using LABAs for asthma treatment.

FDA is implementing a mandatory Risk Evaluation and Mitigation Strategy (REMS) which includes a revised Medication Guide for patients and a plan to educate healthcare professionals about the appropriate use of LABAs.  In addition, FDA is requiring manufacturers to conduct clinical trials to evaluate the safety of LABAs when used in combination with inhaled corticosteroids.

To ensure the safe use of these products:

• Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
• LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
• LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved.  Patients should then be maintained on asthma controller medication.
• Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.

FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs.  FDA believes the safety measures recommended above will improve the safe use of these drugs.

Please read the complete MedWatch 2010 Safety Summary for more information.