New Precautions For Singulair, Accolate, And Zyflo

Singulair, Accolate, Zyflo and Zyflo CR have modified their labeling to include information about neuropsychiatric events occurring in patients using these products. Events that patients and health care providers need to be aware of include:

• agitation
• aggression
• anxiousness
• dream abnormalities
• hallucinations
• depression
• insomnia
• irritability
• restlessness
• suicidal thinking and behavior
• suicide
• tremor

In a June blog I commented that the FDA had noted the possibility of these events occurring and was requesting the manufacturers change their labeling. While the labels have been now been changed, the FDA still advises the following:

• Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
• Patients should talk with their healthcare providers if these events occur.
• Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.

The latest prescribing information for these products can be found on the FDA website.