Neuropsychiatric Events with Certain Asthma Drugs (Singulair, Zyflo, Zyflo CR, Accolate)

FDA has asked the manufacturers of leukotriene-modifying drugs to include a precaution in their labeling about the potential for neuropsychiatric events with these medications. The drugs include Accolate (zafirlukast), Zyflo (zileuton) and Zyflo CR (zileuton), which are used to treat asthma, and Singulair (montelukast), which is used to treat asthma and allergic rhinitis, and to prevent exercise-induced asthma.

Reported neuropsychiatric events with these drugs have included agitation, aggression, anxiousness, irritability, restlessness and insomnia. Patients have also experienced tremors, dream abnormalities, hallucinations, depression and suicidality, including suicide.

Healthcare professionals should be alert to the possibility of neuropsychiatric events in patients taking leukotriene modifiers, and should advise patients to report neuropsychiatric symptoms if they occur. If these symptoms develop, clinicians should consider discontinuing the medication.

FDA Patient Safety News: August 2009

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=89#2

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