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On June 12, 2009, the U.S. Food and Drug Administration (FDA) requested that the makers of Singulair (montelukast) and similar drugs (leukotriene receptor antagonists) update the label on these products to warn of the risk for neuropsychiatric events such as depression, suicidal thinking, agitation, and insomnia.
Singulair is used for maintenance treatment of asthma and to relieve symptoms of seasonal allergies. It works by reducing the bronchoconstriction and inflammation by binding to leukotriene, which would otherwise cause it. This method of operation does not make it useful for acute asthma attacks. But because of its specific scope of action, it tends not to interact with other allergy medications.
After a high number of the neuropsychiatric events were reported, the FDA conducted a post market review. In its subsequent safety information update, it advises patients and healthcare professionals to:
- Be aware of the potential for neuropsychiatric events, including aggression, agitation, anxiousness, depression, dream abnormalities and hallucinations, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor, with the use of these medications
- Talk with each other if any such events occur
- Consider discontinuing use of this type of medication
The other two drugs cited in the FDA alert are Accolate (zafirlukast) Zyflo (zileuton).
Other side effects that have been associated with the use of Singulair and some other leukotriene receptor antagonists include:
- Gastrointestinal disturbances
- Hypersensitivity reactions
- Other sleep disorders (in addition to insomnia)
- A higher incidence of Churg-Strauss syndrome
If you or a loved one has experienced any of the side effects associated with Singulair or other leukotriene receptor antagonists, you may be entitled to compensation. For an evaluation of your case, contact a qualified pharmaceutical injury attorney.