Evelyn Pringle June 2009
The requirement for a more prominent warning regarding an increased risk of neuropsyhiatric events, including suicide, applies to Singulair (montelukast), and Accolate (zafirlukast), leukotriene receptor antagonists, and Zyflo and Zyflo CR (zileuton), a leukotriene synthesis inhibitor.
The reported neuropsychiatric events "include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor," the FDA said in a June 12, 2009, statement on its Website.
"Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications," the FDA states.
"FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling)," the agency notes.
Singulair, Accolate, and Zyflo are approved to treat asthma, and Singulair is also approved to treat allergic rhinitis and prevent exercise induced asthma.
In March 2008, the FDA announced that Singulair may be associated with suicidality and suicide, and subsequently conducted a review of neuropsychiatric events in post marketing reports and clinical trial data submitted by the drug makers.
Events were not found to be common in the clinical trials but the trials were not designed to look for neuropsychiatric events, the FDA said. "Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo," the agency noted.
AstraZeneca markets Accolate, and Zyflo is made by Cornerstone Therapeutics. Singulair was Merck's top selling product in 2008, and the sixth top selling drug in the US, with sales of $3.5 billion, according a March 2009 report by IMS Health.