Study Finds No Link Between Side Effects of Serevent and Risk of Serious Asthma Events

CORRECTED 5/15/17: Earlier version misidentified Flovent as Flonase.

The findings of new research raises questions about whether the side effects of Serevent (salmeterol) include an increased risk of severe and potentially life-threatening asthma problems. 

In a study published last week in the New England Journal of Medicine, researchers associated with GlaxoSmithKline, Serevent’s manufacturer, sought to determine whether a class of chronic pulmonary obstructive disease (COPD) drugs, known as long-acting beta-agonists (LABAs), may actually cause individuals to face a greater risk of adverse events when used to treat asthma.

Federal health regulators have previously warned that Serevent and other long-acting beta agonists, such as Advair, Symbicoort and Foradil, should never be used alone to treat asthma in children and adults. An FDA statement about the risks associated with the medications was issued in February 2010, after studies raised concerns that long-term use of LABAs may cause a worsening of asthma symptoms and death in some users.

In this latest study, researchers conducted a multicenter-randomized, double-blind clinical trial of both adolescent and adult patients, starting at age 12. A total of 11,679 patients were enrolled, all of whom had a history of severe asthma events in the year before the trial began, but not during the previous month before the trial began. The trial excluded patients with a history of life-threatening and unstable asthma.

Some patients were given Serevent combined with Flovent (fluticasone), a nasal allergy spray and others were given just Flovent for 26 weeks. According to the findings, there was no increased risk of serious asthma-related events among those who took both Serevent and Flovent, and in fact the researchers found that the risk of severe asthma exacerbation was 21% lower in the group that took both medications.

“Patients who received salmeterol in a fixed-dose combination with fluticasone did not have a significantly higher-risk of serious asthma-related events than those who received fluticasone alone,” the researchers determined.

Asthma affects 20 million Americans, including 6.5 million children. It is a chronic disease with symptoms like wheezing, difficulty breathing and spasms, which can severely limit activities and impact quality of life.

Prior FDA warnings indicate that Foradil, Advair, Symbicort and Serevent side effects may mask worsening inflammation in the airways, and worsening asthma symptoms may not be recognized in a timely manner, potentially leading to severe health risks and death. This new findings appear to contradict those findings with respect to Serevent.