FDA Investigating Link Between Singulair and Suicide

Chrissie Cole

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The U.S. Food and Drug Administration (FDA), is investigating a possible link between the use of Singulair and suicidal behavior, mood changes and suicide.

Singulair, a leukotrient receptor antagonist, is used to treat asthma and the symptoms of rhinitis (irritation and inflammation of the nose), while preventing exercise-induced asthma episodes.

Patients are advised not to stop taking Singluair prior to talking to their medical doctor. Healthcare professions should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in mood and behavior.

In the past year alone, Merck has updated the drug's labeling four times to include information on a growing range of reported side effects including: anxiousness, depression, suicidal behavior and tremors.

Merck officials stressed that the FDA's inquiry is based on reports, not clinical studies -- which are the standard tool for evaluating drug safety. The company said none of the 11,000 patients enrolled in 40 Singulair trials has committed suicide.