Safety Alert: Montelukast
Update on FDA Safety Review
The FDA has provided an update on the safety of montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo, Zyflo CR), medicines that are commonly used to treat asthma and allergies. The FDA first began reviewing the clinical study safety data on these medicines and suicide, suicidality (suicidal thinking and behavior) and other behavior and mood changes in March 2008.
The FDA has concluded that the data does not suggest that montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo, Zyflo CR) are associated with suicide or suicidal behavior. However, the FDA has not yet reached a conclusion about the link between montelukast, zafirlukast, and zileuton and mood and behavioral side effects. The FDA will continue to review the data and will communicate any recommendations to the public when the review is finished.
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What does this mean?
Most patients using montelukast (Singulair) will find the benefits of the medicine outweigh the side effects. That said, if you use montelukast (Singulair), you should watch out for signs of behavior or mood changes or depression, and contact your doctor if these symptoms occur. Because montelukast (Singulair) is commonly used to treat serious illnesses, it is important that you do NOT stop taking your medicine before talking to your doctor.
