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Possible Link Between Montelukast and Suicidality, US FDA Investigates
WASHINGTON, DC -- March 27, 2008 -- The US Food and Drug Administration has informed healthcare professionals and patients of the agency's investigation of a possible association between the use of montelukast (Singulair) and behaviour/mood changes, suicidality, and suicide. Montelukast is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis and to prevent exercise-induced asthma.
The FDA issued an "Early Communication" stating that the agency is working with Merck & Co, Inc., makers of Singulair, to further evaluate a possible link between use of the drug and behaviour/mood changes, suicidality, and suicide in response to inquiries received by the FDA. The agency has requested that Merck evaluate montelukast study data for more information about suicidality and suicide. The FDA is reviewing the postmarketing reports it has received regarding behaviour/mood changes, suicidality, and suicide in patients who took montelukast.
Due to the complexity of the analyses, the FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, the FDA will communicate the conclusions and recommendations to the public.
Until further information is available, healthcare professionals and caregivers should monitor patients taking montelukast for suicidality and changes in behaviour 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. The FDA is reviewing postmarketing reports it has received of behaviour/mood changes, suicidality, and suicide in patients who took these drugs and will assess whether further investigation is warranted.
The FDA urges both healthcare professionals and patients to report side effects from the use of montelukast, zafirlukast, and zileuton to the FDA's MedWatch Adverse Event Reporting program.
Source: US Food and Drug Administration
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