Safety Alerts & Recalls

What does this mean?

Most patients using Zileuton will find the benefits of the medicine outweigh the side effects. Although the risk of neuropsychiatric events is low, you should be aware that mood or behavior changes, including depression, anxiousness, irritability, dream abnormalities and insomnia may occur when taking Zileuton. Please contact your doctor or other health care provider if you notice any unexplained changes in your mood, behavior or sleeping patterns.

Because Zileuton is commonly used to treat serious illnesses, it is important that you DO NOT stop taking your medicine before talking to your doctor. If you have any questions or concerns about Zileuton, please follow up with your doctor.

Updated Safety Information from FDA Safety Review

In April 2009, FDA completed its review of neuropsychiatric events (mood and behavioral changes) possibly related to drugs that act through the leukotriene pathway including montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). As part of its review, FDA reviewed post-marketing reports and also requested that manufacturers submit all available information from clinical research studies for these products.

Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). The reported neuropsychiatric events include cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. The FDA has requested that manufacturers include a precaution in the drug prescribing information to inform doctors about these reports of mood and behavior changes.

Montelukast is used to treat asthma, and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma. Zafirlukast and zileuton are used to treat asthma.

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Source: FDA
Publication Date: 2009-06-12
Last Updated: 2009-12-05

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