The FDA ( Food and Drug Administration ) 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, 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 ( suicidal thinking and behavior ) ( 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.
Singulair is an effective medicine that is indicated for the treatment of asthma and symptoms of allergic rhinitis. Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality and changes in behavior and mood.
Other leukotriene modifying medications include Zafirlukast ( Accolate ), which is also a leukotriene receptor antagonist and Zileuton ( Zyflo and Zyflo CR ), which is a leukotriene synthesis inhibitor.
Source: FDA, 2008
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