New Safety Requirement Announced for LABAs

February 19, 2010

AARC participated in a conference call where the Food and Drug Administration (FDA) announced new safety requirements and future label changes for Long-Acting Beta Agonists (LABAs) used in the treatment of asthma. 

Patients with asthma are at greatest risk if LABAs are not prescribed and used properly. The new warnings do not apply to others with pulmonary diseases such as COPD. The safety of pediatric patients and adolescents is of most concern to FDA because misuse of LABAs in this population can result in hospitalizations. FDA will be monitoring prescribing practices in which LABAs are prescribed without the use of another long-term controller.

Highlights of the changes include:

• Use of LABAs without the addition of an asthma controller medication such as an inhaled corticosteriod is contraindicated.  Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should never be used alone.
• LABAs should only be used long-term in asthma patients whose symptoms cannot be controlled adequately on asthma controller medications.
• LABAs should be used short-term in order to get the asthma symptoms under control and stopped, if possible, once that is achieved.  Patients should be then be maintained on an asthma controller medication.
• Pediatric and adolescent patients who need a LABA in addition 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 posted more information about requirements that manufacturers must follow and more information for consumers and health professionals.

Questions and answers about the new findings and safety warnings are also available.

If you want to listen to a replay of the FDA conference call in which these latest safety finding were discussed, it is available until February 28, 2010 at 11:59 PM by calling 800-934-9450.