Singulair gets MedWatch alert for suicide risk
Executive Summary
FDA will likely need nine months to review data potentially linking Merck's asthma treatment Singulair (motelukast) to behavior/mood changes, suicidality and suicide, the agency says in a March 27 MedWatch alert. FDA attributes the lengthy evaluation time to the complexity of the analyses. Merck updated its label four times in the past year to add post-marketing adverse events including tremor, depression, suicidality and, most recently, anxiousness