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American Lung Association Study Finds No Evidence of Depression or Suicide Linked to Asthma and Allergy Drug Montelukast

Monday, September 1, 2008 General News J E 4
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WASHINGTON, Sept. 1 There has been recentconcern that suicide may be a complication of montelukast (Singulair) therapy.Montelukast is a Food and Drug Administration (FDA) approved oral drug thathas been prescribed for more than a decade for the treatment of asthma andseasonal allergy symptoms. An independent study sponsored by the American LungAssociation has found no evidence of depression or suicide linked tomontelukast.

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

"Discovering adverse effects of a drug after it is on the market can bevery difficult, because the data are usually gathered from single eventsreported by doctors, which makes it is challenging to differentiate actualside effects from events unrelated to the drug," said Norman Edelman, MDAmerican Lung Association Chief Medical Officer. "The value of this 'lookback' study is that the investigators were able to compare a large group ofpatients given montelukast with those given a placebo making a firm scientificconclusion possible."

Holbrook and Harik-Khan reviewed quality of life and emotional well beingdata collected from patients in three American Lung Association ACRC Networkclinical trials that had used montelukast as one of their treatments. Of the1,352 patients who participated in the double-blind, controlled studies, 569of these patients had been randomly assigned to take montelukast. Theresearchers analyzed these patients' data and found no evidence of anydeterioration of emotional well being in either the adults or the children whoreceived montelukast. On the contrary, the research team found a positiveeffect on emotional outlook when comparing patients taking montelukast tothose receiving placebo.

While the findings of this study are reassuring and produced no evidenceto support the recent publicity regarding a link between montelukast anddepression or suicide, the authors do not dismiss the possibility that therecould be other unrecognized adverse reactions to montelukast.

The ACRC Network is an American Lung Association-sponsored researchprogram that conducts large-scale clinical trials with the mission ofadvancing the care and treatment of people with asthma. The network, with acentral data coordinating center and 20 clinical centers located across thecountry, is the largest of its kind. By placing its clinical centers aroundthe country, the ACRC Network is able to enroll large numbers of patients forclinical trials, thus ensuring relevant research findings can be interpretedwith the highest level of scientific authority.

Norman Edelman, MD disclosed stock ownership with Johnson & Johnson. JanetHolbrook, PhD, MPH made the following disclosures: Research support by Takedaand Astra-Zeneca; Raida Harik-Khan, PhD had no disclosures.

The American Lung Association has a strict policy of not endorsingproducts. Corporate and educational partnerships affiliated with theAssociation's National Headquarters can be found online at:http://www.lungusa.org/site/c.dvLUK9O0E/b.2827559/k.3BEB/Corporate_Educational_Partnerships.htm (due to URL length, please copy and paste into browser).

About the American Lung Association: Beginning our second century, theAmerican Lung Association is the leading organization working to prevent lungdisease and promote lung health. Lung disease death rates are currentlyincreasing while other major causes of death are declining. The American LungAssociation funds vital research on the causes
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