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American Lung Association Study Finds No Evidence of Depression or Suicide Linked to Asthma and Allergy Drug Montelukast
Date:8/31/2008

WASHINGTON, Sept. 1 /PRNewswire-USNewswire/ -- There has been recent concern that suicide may be a complication of montelukast (Singulair) therapy. Montelukast is a Food and Drug Administration (FDA) approved oral drug that has been prescribed for more than a decade for the treatment of asthma and seasonal allergy symptoms. An independent study sponsored by the American Lung Association has found no evidence of depression or suicide linked to montelukast.

American Lung Association researchers Janet Holbrook, PhD, MPH and Raida Harik-Khan, PhD have re-analyzed data from patients who had participated in past clinical trials involving montelukast conducted by the Association's Asthma Clinical Research Centers (ACRC) Network to identify any signals that might suggest a link between montelukast and its effect on emotional well- being. They report their findings in an upcoming issue of the Journal of Allergy and Clinical Immunology.

"Discovering adverse effects of a drug after it is on the market can be very difficult, because the data are usually gathered from single events reported by doctors, which makes it is challenging to differentiate actual side effects from events unrelated to the drug," said Norman Edelman, MD American Lung Association Chief Medical Officer. "The value of this 'look back' study is that the investigators were able to compare a large group of patients given montelukast with those given a placebo making a firm scientific conclusion possible."

Holbrook and Harik-Khan reviewed quality of life and emotional well being data collected from patients in three American Lung Association ACRC Network clinical trials that had used montelukast as one of their treatments. Of the 1,352 patients who participated in the double-blind, controlled studies, 569 of these patients had been randomly assigned to take montelukast. The researchers analyzed these patients' data and found no evidence of any deterioration of emotional well being in
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SOURCE American Lung Association
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