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A meta-analysis of four large-scale clinical trials supports the safety and efficacy of a combination drug used in the treatment of asthma. The conclusions support an earlier FDA decision to remove the boxed warning on drugs containing a long-acting beta-2 agonist (called a “LABA”) combined with an inhaled glucocorticoid. An example of this type of drug is AstraZeneca’s Symbicort®, which is a combination budesonide-formoterol used in asthma treatment.

Dr. Paul O’Byrne was part of the international joint oversight committee that analyzed the clinical data to reach the determination of the drug’s safety. O’Byrne is a clinician scientist at the Firestone Institute for Respiratory Health at St. Joseph’s Healthcare Hamilton and professor of medicine at McMaster University’s Michael G. DeGroote School of Medicine.  

“There have been some safety concerns around LABAs when they are administered alone in the management of asthma, which raised questions about its impact when taken with an inhaled glucocorticoid,” said Dr. O’Byrne.

The meta-analysis was published in the June 28, 2018 issue of the New England Journal of Medicine, one of the world’s most influential medical journals. O’Byrne has had two recent publications in the same journal that examined the benefits of the combined drug over alternate treatments consisting of terbutaline.

The combined drug may prove to be a preferred treatment, as the data “confirmed a lower relative risk of asthma exacerbations of 17% with combination therapy than with an inhaled glucocorticoid alone,” according to the meta-analysis.

Previously, the combined drug was sold in the United States with an FDA-mandated boxed label, which may have deterred usage based on the assumption of danger associated with the warning. The FDA removed the boxed warning in December 2017, in light of the revelations of the meta-analysis.

 

FDA Boxed Warning

In 2003, the FDA placed a boxed warning (sometimes called a “black box” warning) on the combined drug. This is the strictest warning mandated by the FDA, used to communicate a serious hazard associated with a particular drug.

Though the FDA performed its own studies on the drug’s safety, they were unable to reach a definitive conclusion due to the small patient enrollment numbers. The four companies marketing the combined drug (AstraZeneca, GlaxoSmithKline, Merck, and Novartis) were mandated by the FDA in 2010 to perform in-depth clinical trials to test its safety.

The four manufacturers harmonized their trial methods, allowing an independent joint oversight committee to perform the final analysis. The committee used combined data from over 36,000 participants in four individual trials to reach their conclusion on the safety of the drug.

In December 2017, the FDA removed its boxed warning from combined glucocorticoid-LABA drugs after the evidence demonstrated the safety of these medications for use in the treatment of asthma.

According to an official statement, “Removal of a boxed warning isn’t common, but we at the FDA believe that the data generated from the mandated trials support this regulatory action.” The FDA perspective was published in the same issue of the New England Journal of Medicine as the meta-analysis.

In the same statement, the FDA noted that the decision to immediately remove the boxed warning was supported by the “strong and consistent evidence” from the clinical trials.

 

 

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