FDA Removes Boxed Warning From Certain Asthma Medications

Share this content:
FDA Removes Boxed Warning From Certain Asthma Medications
FDA Removes Boxed Warning From Certain Asthma Medications

TUESDAY, Dec. 26, 2017 (HealthDay News) -- New evidence regarding safety is spurring the U.S. Food and Drug Administration to remove a Boxed Warning from certain inhaled medications used to treat asthma and chronic obstructive pulmonary disease.

The decision applies to long-acting beta agonists (LABAs) used in combination with inhaled corticosteroid (ICS) medications. Brand names for these products include Advair, Airduo, Breo, Dulera, and Symbicort.

In 2011, the FDA told makers of such medicines to conduct large safety trials to assess the risk of serious side effects such as hospitalization, intubation, and death among asthma patients. A review of data from those trials found 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," the FDA said.

However, the agency said that "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 FDA also noted that labeling on medicines that contain both an ICS and LABAs will still have a Warning and Precaution about the risk of using LABAs without an ICS for asthma and will provide information on the completed safety trials.

More Information

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »

Drug Lookup

Browse drugs by: BrandGenericDisease



Sign up for myCME e-newsletters


More in Home

Study Finds 31 Percent Use No Opioids After Surgery

Study Finds 31 Percent Use No Opioids After ...

At discharge, 92.2 percent of patients received an opioid prescription; nearly 63 percent unused

PAs May Have Lower Diagnostic Accuracy for Melanoma

PAs May Have Lower Diagnostic Accuracy for Melanoma

PAs diagnose fewer melanomas in situ, perform more skin biopsies per case of skin cancer diagnosed

AAN: Neuromodulation Therapy Gives Relief From Hand Tremor

AAN: Neuromodulation Therapy Gives Relief From Hand Tremor

Non-invasive neuromodulation therapy using a custom stimulation pattern safe for essential tremor

is free, fast, and customized just for you!

Already a member?

Sign In Now »