The agency last March announced that it was reviewing data that raised concerns about a possible association between the use of Singulair and behavior/mood changes, suicide, suicidal thinking and suicidal behavior.

The FDA has urged both healthcare professionals and patients to report side effects from the use of drugs Singulair, Accolate, Zyflo, and Zyflo CR to the FDA's MedWatch Adverse Event Reporting program.

The review was initiated by post-marketing reports of neuropsychiatric events associated with montelukast, zafirlukast and zileuton being reported to FDA's Adverse Event Reporting System.

The FDA said most of the reports of neuropsychiatric events are associated with montelukast -- marketed as Singulair -- currently the most commonly prescribed drug that acts through the leukotriene pathway.