The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
FDA and the manufacturers of Singulair (montelukast), Accolate (zafirlukast), Zyflo (zileuton) and Zyflo CR (zileuton extended release) are announcing an update to the Precautions section of the prescribing information to include information about neuropsychiatric events reported in patients using these products.
For more information, visit:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm
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