FDA Removes Advair, Symbicort Boxed Warnings For Death Risks

Federal regulators are removing a “black box” warning that was previously placed on the asthma inhalers Advair, Dulera and Symbicort, after a number of recent studies found that the medications do not increase the risk of death.

Since 2010, certain a boxed warning on the asthma inhalers indicated that users may be at risk of sudden death. The label warning was the strongest the FDA can place on a prescription medication, but it will now be removed.

The inhalers all belong to a class of medications that were a combination of long-acting beta agonists (LABAs) and inhaled corticosteroids (ICS), which the FDA indicates no longer appear to carry the same serious risks the agency originally thought.

In a drug safety communication issued on December 20, the FDA indicates that four large clinical safety trials provide further information, and indicate that the drugs do not increase the risk of serious asthma-related side effects when compared to treatment with inhaled corticosteroids alone.

The studies were commissioned by the FDA in 2011, to get a better understanding of the health risks of LABA/ICS combination asthma treatments. The four studies involved 41,297 patients who were treated for six months. According to the findings of all of the trials, one of which specifically involved children, the inhalers did not significantly increase the risk of serious asthma problems. The agency also indicates that the trials showed that the drugs decreased asthma attacks when compared to inhaled corticosteroids alone.

The list of approved LABA/ICS asthma inhalers includes Advair Diskus, Advair HFA, Airduo Respiclick, Breo Ellipta, Dulera and Symbicort.

The FDA also noted that using long-acting beta agonists alone for the treatment of lung inflammation is still associated with an increased risk of asthma-related death, and a black box warning about those risks will remain in place for all single-ingredient LABA medications.

Asthma is a chronic disease which affects 20 million Americans, including 6.5 million children, causing symptoms like difficulty breathing, spasms and wheezing.

Unlike rescue inhalers, which contain the beta-agonist albuterol and have a limited duration, these long-acting beta agonists are designed to be taken daily to prevent asthma attacks.