FDA Removes Warning for Some Inhalers

Asthma-related death warning removed for some combination inhalers

(RxWiki News) The US Food and Drug Administration (FDA) has removed a strong warning for some combination inhalers.

The FDA recently explained that treating asthma with combination inhalers (those that contain long-acting beta agonists (LABAs) and inhaled corticosteroids (ICS)) may not lead to significantly more serious issues related to asthma when compared to people who were treated with an ICS alone, according to four large clinical safety trials.

These recent clinical trials looked at whether these particular combination inhalers led to asthma-related hospitalizations, the need to insert a breathing tube (known as intubation), or asthma-related deaths.

Combination inhalers like Advair and Symbicort are currently approved to treat asthma and chronic obstructive pulmonary disease (COPD). The inhaled corticosteroids help decrease inflammation in the lungs, while LABAs help keep the muscles in the lungs relaxed in order to prevent symptoms like wheezing, chest tightness and shortness of breath.

Up until now, these particular combination inhalers included a boxed warning — the strongest type of warning — about asthma-related death on their labels. However, the recent clinical trials showed that LABAs, when used with ICS, did not significantly increase the risk for these asthma-related issues. As a result, the boxed warning has been removed for Advair, Airduo, Breo, Dulera and Symbicort.

It is important to note that the boxed warning will remain on the labels of all single-ingredient LABA medicines, according to the FDA.

Do not stop using your asthma medicines without first talking to your health care provider. Speak with your health care provider if you have any questions or concerns about asthma medication.

Last Updated:
December 29, 2017