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Title: Montelukast Does Not Cause Depression or Suicide, American Lung Association Study Concludes
URL: http://www.pslgroup.com/dg/22A7F2.htm
Doctor's Guide
September 3, 2008

WASHINGTON, DC -- September 3, 2008 -- An independent study sponsored by the American Lung Association has found no evidence of depression or suicide linked to montelukast. They report their findings in an upcoming issue of the Journal of Allergy and Clinical Immunology.

Janet Holbrook, PhD, and Raida Harik-Khan, PhD, have re-analysed data from patients who had participated in past clinical trials involving montelukast conducted by the American Lung 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.

"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, Washington, DC.

"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."

Drs. Holbrook and Harik-Khan reviewed quality of life and emotional well-being data collected from patients in 3 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 analysed these patients' data and found no evidence of any deterioration of emotional well-being in either the adults or the children who received montelukast.

On the contrary, the research team found a positive effect on emotional outlook when comparing patients taking montelukast to those receiving placebo.

While the findings of this study are reassuring and produced no evidence to support the recent publicity regarding a link between montelukast and depression or suicide, the authors do not dismiss the possibility that there could be other unrecognised adverse reactions to montelukast.


SOURCE: American Lung Association

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