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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
Generic zithromax pills no prescription 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 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 unrecognized adverse reactions to
montelukast.
The ACRC Network is an American Lung Association-sponsored research
program that conducts large-scale clinical trials with the mission of
advancing the care and treatment of people with asthma. The network, with a
central data coordinating center and 20 clinical centers located across the
country, is the largest of its kind. By placing its clinical centers around
the country, the ACRC Network is able to enroll large numbers of patients
for clinical trials, thus ensuring relevant research findings can be
interpreted with the highest level of scientific authority.
Norman Edelman, MD disclosed stock ownership with Johnson & Johnson.
Janet Holbrook, PhD, MPH made the following disclosures: Research support
by Takeda and Astra-Zeneca; Raida Harik-Khan, PhD had no disclosures.
About the American Lung Association: Beginning our second century, the
American Lung Association is the leading organization working to prevent
lung disease and promote lung health. Lung disease death rates are
currently increasing while other major causes of death are declining. The
American Lung Association funds vital research on the causes of and
treatments for lung disease. With the generous support of the public, the
American Lung Association is "Improving life, one breath at a time."
American Lung Association

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