The FDA has removed the requirement for manufacturers to include the black box warning about asthma-related death from the drug labels of medicines that contain both an inhaled corticosteroid (ICS) and a long-acting beta-agonist (LABA), according to an agency announcement.
According to the FDA, a review of four large clinical safety trials shows that treating asthma with LABAs in combination with ICS does not result in significantly more serious asthma-related side effects than treatment with ICS alone.
A description of the four trials is now also included in the Warnings and Precautions section of the drug labels. These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, intubation, or asthma-related deaths, compared to ICS alone.
The dropped requirement will affect ICS/LABA combinations like Symbicort (AstraZenaca), Advair Diskus (GSK), Advair HFA (GSK), Breo Ellipta (GSK), Dulera (Merck), and Airduo Respiclick (Teva Pharma).
The FDA recommends the following:
- Healthcare professionals should refer to the most recently approved drug labels for recommendations on using ICS/LABA medicines (see links in Table 1 of the Drug Safety Communication).
- Patients and parents/caregivers should talk to your healthcare professional if you have any questions or concerns. Do not stop taking your asthma medicines without first talking to your healthcare professional. Also read the patient information leaflet that comes with every prescription.
- Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.