Product Liability

Lung treatment safety labels now carry asthma-related death warning

symbicort box inhaler 47404 47405 100x100 Lung treatment safety labels now carry asthma related death warningThe safety labels on Long-Acting Beta Agonists (LABAs) used for the treatment of lung diseases such as asthma and chronic obstructive pulmonary disease (COPD) now carry a black box warning about LABAs increasing the risk of asthma-related death, according to the Food and Drug Administration (FDA). A black box warning is the strongest warning the agency can give and is reserved for drugs that carry a significant risk of serious or even life-threatening adverse events. The new recommendations in the updated labels also state that use of LABAs alone without the use of a long-term asthma control medication, such as an inhaled corticosteroid, is “absolutely advised against” in the treatment of asthma.

The label changes were approved for the following LABAs:
• Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder)
• Advair HFA Inhalation Aerosol (fluticasone propionate and salmeterol xinafoate)
• Brovana Inhalation Solution (arformoterol tartrate)
• Foradil Aerolizer (formoterol fumarate inhalation powder)
• Foradil Certihaler (formoterol fumarate inhalation powder)
• Perforomist (formoterol fumarate) Inhalation Solution
• Serevent Diskus (salmeterol xinafoate inhalation powder)
• Symbicort Inhalation Aerosol (budesonide and formoterol)

The FDA first announced the boxed warning on LABAs in February based on an analysis of clinical trials of LABAs that showed the drugs are associated with an increased risk of severe worsening of asthma symptoms leading to hospitalization in both children and adults, and death in some patients with asthma.