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FDA Investigates Possible Link Between Singulair and Suicidal Behavior

The FDA has issued an early communication about potential associations 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.

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.

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).

LINK(S):

FDA early communication (Free)

Associated Press story (Free)

FDA's MedWatch reporting site (Free)

Singulair prescribing information (Free PDF)

Published in Physician's First Watch March 28, 2008