Drug Notebook

FDA Alerts

Special Alerts:

[Posted 03/27/2008] FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of montelukast (Singulair) and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Montelukast is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma. Patients should not stop taking montelukast before talking to their doctor if they have questions about the new information. Healthcare professionals and caregivers should monitor patients taking montelukast for suicidality (suicidal thinking and behavior) and changes in behavior and mood.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Singulair and http://www.fda.gov/cder/drug/early_comm/montelukast.htm.

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montelukast
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(mon the LOO kast)

What is the most important information I should know about montelukast?

Do not use montelukast to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medication to treat an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks. It may take up to several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after several weeks of treatment.

Call your doctor right away if you feel that this medicine is not working as well as usual, or if it makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

If you already take this medication to prevent asthma or allergy symptoms, do not use it for exercise-induced bronchoconstriction. Call your doctor at once if you have any mood or behavior changes, anxiety, depression, or thoughts about suicide or hurting yourself.

What is montelukast?

Montelukast is a leukotriene (loo-koe-TRY-een) inhibitor. Leukotrienes are chemicals your body releases when you breathe in an allergen (such as pollen). These chemicals cause swelling in your lungs and tightening of the muscles around your airways, which can result in asthma symptoms.

Montelukast is used to prevent asthma attacks in adults and children as young as 12 months old. It is also used to relieve runny nose and sneezing caused by allergies in adults and children as young as 6 months old.

Do not give this medication to a child without a doctor's advice.

Montelukast is also used to prevent exercise-induced bronchoconstriction (narrowing of the air passages in the lungs) in people who are not already taking this medicine for other conditions.

If you already take this medication to prevent asthma or allergy symptoms, do not use it for exercise-induced bronchoconstriction.

Montelukast may also be used for other purposes not listed in this medication guide.

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