Singulair Adverse Event Reporting System, Zileuton, Montelukast, Clinical Details, Zafirlukast

On January 13, 2009, the FDA released a Follow-up to their March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair). Included in this update is the following information:

"Post-marketing reports of neuropsychiatric events associated with montelukast, zafirlukast and zileuton have been reported to FDA’s Adverse Event Reporting System (AERS). Most of the reports of neuropsychiatric events are associated with montelukast, currently the most commonly prescribed drug that acts through the leukotriene pathway. The clinical details of some reports involving montelukast are consistent with a drug-induced effect. Because of the paucity of reports involving zafirlukast and zileuton, assessment of a drug–induced effect with these is limited. Accordingly, at this time, patients and prescribers should monitor for the possibility of neuropsychiatric events associated with these agents."