FDA Requests Labeling Change for Leukotriene Modifiers

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA Requests Labeling Change for Leukotriene Modifiers

FDA Requests Labeling Change for Leukotriene Modifiers
Fri, 12 Jun 2009 14:05:00 -0500

The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).

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