Singulair, the best-selling allergy medicine by Merck, is being investigated by the Food & Drug Administration after reports that the drug is linked to suicide.
FDA said it is reviewing a number of reports involving mood changes, suicidal behavior and suicide in patients who have taken Singulair.
Merck has updated the drug's labeling four times in the past year to include information on a range of reported side effects: tremors, anxiousness, depression and suicidal behavior.
Merck said that they have done clinical studies to test the side effects of the drug. The company said none of the 11,000 patients enrolled in 40 Singulair trials has committed suicide.
It could take up to nine months before agency scientists can draw any conclusions, FDA said in a posting to its Web site.
Singulair, an allergy and asthma medication, garnered sales $4.3 billion last year. The drug is in the same allergy and asthma classification as AstraZeneca's Accolate and Critical Therapeutics's Zyflo.
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