Montelukast (Singulair) and Risk of Behavior Changes, Mood Changes, or Suicidality - Ongoing Safety Review
June 12, 2009
FDA informed healthcare professionals of an ongoing analysis of safety data of montelukast (Singular) in March 2008. Merck has updated the package insert since that time to include warnings about additional adverse events reported in postmarketing, including tremor, depression, suicidality, and anxiousness. In addition, FDA has received reports of behavior changes, mood changes, and suicidality with montelukast and other leukotriene antagonists (ie, zafirlukast, zileuton).
Merck and FDA worked together to evaluate these postmarketing data for any association between montelukast and these events. FDA also evaluated whether additional studies are needed for the other available leukotriene antagonists. An analysis of placebo-controlled clinical trials found no association between montelukast, zafirlukast, or zileuton and suicide or suicidal behavior. However, because these clinical trials were not designed to examine these events, FDA will continue to review clinical trial data for other neuropsychiatric events, (mood and behavioral adverse events) related to these medications.
Educate patients not to discontinue montelukast and consult their healthcare provider with any questions about this information. Monitor patients on montelukast for any signs of behavior changes, mood changes, or suicidality, and report any such events to the FDA at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. Additional information is available at the following links:
- FDA MedWatch alert:
- Updated Information on Leukotriene Inhibitors, June 12, 2009:
- Follow Up to March 27, 2008 Communication:
- Early Communication about Ongoing Safety Review, March 27, 2008:
June 12, 2009; March 27, 2008; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.