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:
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.