FDA Says LABA Asthma Drugs Not for Solo Use. MedPage Today (By John Gever, Senior Editor). February 18, 2010. Long-acting beta agonist (LABA) agents should never be used alone in children or adults with asthma, the FDA said today in announcing label changes and other initiatives intended to promote safe use of these popular drugs.Package inserts for the two single-agent LABAs approved for asthma, salmeterol (Serevent) and formoterol (Foradil), will be changed to require that the drugs always be used in combination with an asthma controller medication such as an inhaled corticosteroid, according to the FDA.Other new items to be required on the products’ labels include:

• LABAs should only be used long-term in patients with asthma not adequately controlled with inhaled steroids or other controller medications.
• The agents should be used for the shortest time possible to achieve symptom control. Once patients are no longer experiencing symptoms, LABAs should be discontinued if possible with patients maintained on controller medications alone.
• Children and adolescents needing a LABA should use a combination product that also contains an inhaled steroid to ensure compliance with both medications.
  

The FDA is not requiring any label changes for another LABA drug, arformoterol (Brovana), or a version of formoterol sold as Perforomist, which are approved only for chronic obstructive pulmonary disease (COPD). [ See ]

Asthma Drug Warning. CBSNewsOnline. December 12, 2008. The FDA has ruled that two popular asthma drugs, Servent and Foradil, are not safe for use and may actually worsen asthma in some patients. Dr. Jon LaPook reports.