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FDA in Brief: FDA approves removal of Boxed Warning from some inhaled medications used to treat asthma and chronic obstructive pulmonary disease

For Immediate Release: Dec. 21, 2017

Media Inquiries

  Lauren Smith Dyer
  301-348-1888

"As part of our commitment to protecting the health of patients, the FDA continues to monitor drugs after they’re approved. The FDA’s approval to remove the Boxed Warning from a class of medications known as Long-Acting Beta Agonists (LABAs) used in combination with inhaled corticosteroid (ICS) shows that data from the post-market studies we require give the agency actionable safety information on approved drug products,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to an informed and comprehensive approach to monitoring the safety of approved drugs and we adjust our regulatory actions as appropriate based on additional information."

In its Drug Safety Communication, the FDA is alerting health care professionals and patients about new information for a class of medications known as Long-Acting Beta Agonists (LABAs) used in combination with inhaled corticosteroid (ICS) medicines to treat asthma. ICS medicines help decrease inflammation in the lungs. Medicines that contain both ICS and LABA are FDA-approved to treat asthma and chronic obstructive pulmonary disease (COPD). LABAs help the muscles around the airways in the lungs stay relaxed to prevent symptoms such as wheezing, coughing, chest tightness and shortness of breath. Medicines that contain both an ICS and LABA are marketed under several brand names, including Advair, Airduo, Breo, Dulera and Symbicort (See the Drugs@FDA database, where you can search for approved drugs by name).

In 2011, the FDA required the sponsors of combination drug products that contain both an ICS and LABA to conduct large safety trials evaluating the risk of serious asthma outcomes (hospitalizations, intubations, death) in patients with asthma. The FDA’s review of the data resulting from these post-market requirement (PMR) trials finds that treating asthma with LABAs in combination with ICS medicines does not result in significantly more serious asthma-related side effects than ICS alone. Based on these results, the FDA has approved changes to the labeling of these products removing the Boxed Warning about asthma-related death.

Using LABAs alone to treat asthma without an ICS to treat lung inflammation is associated with an increased risk of asthma-related death. Therefore, the Boxed Warning stating this will remain in the labeling of all single-ingredient LABA medicines. The labeling of medicines that contain both an ICS and LABA also will retain a Warning and Precaution related to the risk of using LABAs without an ICS for asthma and provide information on the completed safety trials.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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