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The FDA issued an early communication about a possible link between the asthma and allergy drug montelukast (Singulair) and behavior and mood changes, suicidality, and suicide, based on postmarketing reports.
The agency's investigation was triggered by three or four reports of suicide since October, according to the Associated Press.
Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and allergy symptoms, such as sneezing, stuffy nose, runny nose, and itching of the nose. It is also used to prevent exercise induced asthma.
The FDA is working with Singulair’s maker, Merck & Co, Inc., to further evaluate the possible link between the use of Singulair and behavior/mood changes, suicidality and suicide. The FDA expects that it may take up to 9 months to complete the ongoing evaluations. In addition, the agency is reviewing postmarketing reports of similar behavior in patients taking other leukotriene-modifying medications, including zafirlukast (Accolate) and zileuton (Zyflo and Zyflo CR).
Until more information becomes available, healthcare providers should monitor patients taking Singulair for mood changes and suicidal thinking and behavior, the FDA says. The agency asks that clinicians and patients report side effects on its MedWatch site.
Note - Do not change medications without first consulting your doctor.
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