Home 7. Singulair (Montelukast)

Singulair (Montelukast)

Singulair, a leukotriene receptor antagonist, is used in the treatment of asthma and to relieve symptoms of seasonal allergies.  The drug works by controlling leukotrienes, which are released during allergic reactions that may lead to inflammation, congestion and other allergy and asthma symptoms.  Singulair is manufactured by Merck, and was approved by the FDA in February of 1998.

Use of Singulair may result in a number of side effects, including stomach pain, heartburn, fatigue, fever, cough, upper respiratory infection, dizziness, headache and rash.

In 2008, after receiving reports of suicide among users of Singulair, the FDA issued a communication stating that it was investigating a possible association between the use of Singulair and suicide, behavior/mood changes and suicidality (suicidal thinking and behavior).  The FDA warned healthcare providers to carefully monitor patients taking the drug for mood changes and signs of suicidal thoughts.  The FDA requested that Merck further analyze its data for more information about suicide and suicidality.  In addition, the FDA is continuing its review of Singulair.