The FDA said in a Drug Safety Communication that it has approved the removal of Boxed Warnings about asthma-related deaths from ICS/LABA combination inhalers. The inhalers affected by the change are Advair Diskus, Advair HFA, Breo Ellipta, AirDuo Respiclick, Dulera, and Symbicort.
According to the agency, data from recent post-market requirement trials that involved over 41,000 patients showed no significant increase in asthma-related adverse effects for ICS/LABA therapy compared to ICS only.
Boxed Warnings will remain for LABA-only inhalers, and ICS/LABA inhaler labels “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,” the agency said.
FDA Center for Drug Evaluation and Research Director Janet Woodcock commented, “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. 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.”
Read the FDA Drug Safety Communication.
