June 16, 2009
Leukotriene modifier drug label change requested by FDAThe FDA has requested that manufacturers of leukotriene modifiers include a precaution in the drug labeling regarding neuropsychiatric events that have been reported in some patients taking montelukast (Singulair, from Merck), zafirlukast (Accolate, from AstraZeneca) and zileuton (Zyflo CR from Cornerstone Therapeutics). The reported neuropsychiatric events include agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.
Montelukast is used to treat asthma and the symptoms of allergic rhinitis and to prevent exercise-induced asthma. Zafirlukast and zileuton are used to treat asthma.
For more information visit www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm.