FDA investigates suicide risk in Singulair users

The FDA is investigating a possible association between the use of Singulair (montelukast sodium, from Merck) and behavior/mood changes, suicidality, and suicide. The FDA will review post-marketing reports and has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. In addition to possible suicidality risks, the prescribing information for Singulair has been updated over the past year to include post-marketing events such as tremor, depression, and anxiousness.

Singulair is a leukotriene receptor antagonist indicated for the treatment of asthma and symptoms of allergic rhinitis.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm095019.htm.