The AP (6/13) reported, “Federal health officials are requiring new labels on popular asthma drugs like Merck’s Singulair [montelukast] that highlight language about suicidal behavior, depression and anxiousness seen in a small number of patients.” Specifically, the “alert will be in a section known as ‘precautions’ and advise doctors to use ‘special care’ when prescribing the drug,”  Bloomberg News (6/13, Pettypiece) added. The FDA also stated that “healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.”
According to HealthDay (6/12, Reinberg), the “move follows an ongoing FDA safety review of possible suicidal behavior among those taking asthma drugs.” Agency officials, who began their “review of the data in March 2008, said clinical trial data submitted by the manufacturers of Singulair, Accolate [zafirlukast], and Zyflo [zileuton] suggested the products are not associated with an increased risk of mood changes or suicidal behavior.” But it was also “noted at the time that the trials were not designed to examine such behavior, and that the safety review would continue, probably for several more months.” By April of 2009, investigators discovered “cases of neuropsychiatric events” among some of the reports.