Singulair, Accolate, Zyflo and Zyflo CR have modified their product labeling to include information about certain potential mental health side effects that have been noted 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
If you notice any of these side effects you need to make sure that you immediately talk with your prescribing doctor. The FDA has the following recommendations to patients and providers regarding Singulair side effects and side effects of other leukotriene modifiers:
- 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.
Source:
FDA Post Market Safety Information. Accessed September 7, 2009. Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)
