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Singulair (montelukast)
Audience: Pulmonologists, respiratory therapists, other healthcare professionals, patients
FDA provided updated information to its March 2008 Early Communication. FDA is continuing to review clinical trial data to assess other neuropsychiatric events, (mood and behavioral adverse events) related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As a result, FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with montelukast, zafirlukast, and zileuton.
Read the complete MedWatch Safety summary, including a link to the updated early communication and the original March 2008 communication, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Singulair
You are encouraged to report all serious adverse events and product quality problems for human medical products to MedWatch at: www.fda.gov/medwatch/report.htm.
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