FDA Requests Labeling Change For Leukotriene Modifiers

Main Category: Respiratory / Asthma
Also Included In: Allergy;  Regulatory Affairs / Drug Approvals
Article Date: 15 Jun 2009 - 4:00 PDT

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The U.S. Food and Drug Administration provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. The 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).

Leukotrienes are chemicals the body releases in response to an inflammatory stimulus, such as when a person breathes in an allergen. Montelukast and zafirlukast are leukotriene receptor antagonists that work by blocking leukotrienes. Zileuton is a leukotriene synthesis inhibitor which works by stopping the formation of certain substances that cause swelling, tightening, and mucus production in the airways.

Source
U.S. Food and Drug Administration