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Leukotriene Modifiers for Asthma Associated with Neuropsychiatric Adverse Events
Reports of neuropsychiatric adverse effects from leukotriene modifiers have prompted the FDA to request label changes for these drugs.
The three drugs, used to treat asthma in adults and children aged 12 and older, are montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). Montelukast is also used to treat allergic rhinitis symptoms.
Montelukast and zafirlukast are leukotriene receptor antagonists, and zileuton is an inhibitor of leukotriene synthesis.
The adverse effects, identified in postmarketing surveillance, include agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.
The FDA noted that doctors should consider discontinuing the drugs in patients who develop neuropsychiatric symptoms.
LINK(S):
FDA announcement (Free)
Physician's First Watch coverage of initial FDA warning (Free)
Published in Physician's First Watch June 15, 2009
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