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Singulair: possible association with behavior/mood changes, suicidality and suicide


The FDA ( Food and Drug Adminsitration ) is investigating a possible association between the use of Singulair ( Montelukast ) and behavior/mood changes, suicidality ( suicidal thinking and behavior ) and suicide.

Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma. Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor ( March 2007 ), depression ( April 2007 ), suicidality ( October 2007 ), and anxiousness ( February 2008 ).

FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA.
FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide.
FDA is reviewing the postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair.

Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information.

Source: FDA, 2008

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