Nursing

THE FDA HAS REQUESTED that a psychiatric warning be added to the labels of leukotriene inhibitors such as montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo, Zyflo CR), used to treat asthma and, in the case of montelukast, allergic rhinitis. Changes in mood and behavior have been reported in some patients taking those drugs, including suicides and suicidal thoughts, agitation, aggression, anxiety, dream abnormalities, hallucinations, depression, insomnia, irritability, restlessness, and tremors. Leukotrienes are chemicals the body releases in the presence of an allergen or similar circumstances. The FDA said its recommendation followed a review of neuropsychiatric events that included post-marketing reports and all available clinical trial data.

US Food and Drug Administration. Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR). FDA Web site. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm. Posted June 12, 2009. Accessed July 13, 2009.