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FDA Safety Update: Asthma Medications

Suicidality and Behavior/Mood Changes with Singulair continued...

FDA is working with Merck to perform a complex analysis of Singulair data and will communicate the conclusions and recommendations to the public. The agency is also reviewing postmarketing reports it has received of behavior/mood changes, suicidal thinking, and suicide in patients who have taken Singulair as well as other leukotriene modifying medications, such as Accolate (zafirlukast) and Zyflo (zileuton) and Zyflo CR.

Advice for patients …

Patients should not stop taking these medications before talking to their health care professional about this information. FDA urges patients to report side effects from use of these medications to FDA's MedWatch Adverse Event Reporting Program at:

The Early Communication About an Ongoing Safety Review of Montelukast (Singulair) may be found at:

Safety of Long-Acting Beta Agonists (LABAs)

Bronchodilators are medications that help open up the breathing tubes, but they do not treat the underlying inflammation of asthma. Short-acting bronchodilators are quick-relief medications used for treatment of asthma symptoms. One example is Albuterol. Long-acting beta2 adrenergic agonists (LABAs) are bronchodilators used to provide long-term control of asthma. Examples of medications that contain LABAs and that are approved for use in asthma patients include Advair Diskus (fluticasone propionate; salmeterol xinafoate), Symbicort (budesonide; formoterol fumarate dihydrate), Serevent Diskus (salmeterol xinafoate), and Foradil.

In 2005, FDA issued a Public Health Advisory that alerted health care professionals and patients that LABA medicines may increase the chance of severe asthma episodes and death when the episodes occur. In this advisory, FDA highlighted several recommendations about LABA drugs. For example, LABAs should not be the first medicine used to treat asthma.

In 2006, the manufacturers of Advair Diskus, Foradil Aerolizer, and Serevent Diskus updated product labels with these warnings. Since that time, several additional products containing LABAs have been approved, including Symbicort, Perforomist (formoterol fumarate), and Brovana (arformoterol tartrate). The labels for these products contain similar warnings regarding severe asthma episodes and death.

At a November 2007 Pediatric Advisory Committee meeting, FDA raised concerns about the safety of LABAs in children with asthma. In January 2008, FDA requested manufacturers of Advair Diskus, Advair HFA, Brovana Inhalation Solution, Foradil Aerolizer, Perforomist Inhalation Solution, Serevent Diskus, and Symbicort Inhalation Aerosol to provide information regarding controlled clinical studies conducted with these products to further evaluate their safety. Following the analysis of this data, FDA plans to discuss the benefit and risk of LABAs at a public advisory committee meeting in December 2008.

Advice for patients …
Patients should understand the risks of LABAs and talk with their health care professional about their concerns.

The FDA Public Health Advisory: Advair Diskus, Advair HFA, Brovana, Foradil, Perforomist, Serevent Diskus, and Symbicort Information, may be found at: