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Analysis Shows No Singulair, Suicide Link

Study Suggests Early Improvement in Emotional Well-Being
By
WebMD Health News
Reviewed by Louise Chang, MD

Sept. 5, 2008 -- A new analysis by the American Lung Association does not support a link between the asthma and allergy drug Singulair and depression and suicide.

Researchers combined data from three blinded, case-control studies involving 1,352 children and adults who took either Singulair or placebo.

They found no evidence of deteriorating emotional well-being among users of the asthma and allergy drug.

In fact, the drug seemed to have an opposite effect early in treatment in one trial, with Singulair users scoring higher than placebo users in tests designed to measure emotional status.

(With the conflicting studies and reports, how are you feeling about this drug right now? Talk with others on WebMD's Asthma: Support Group board.)

Findings 'Reassuring'

Approved by the FDA a decade ago, Singulair has become one of drugmaker Merck's top-selling products, with sales of $4.4 billion last year.

But last March, FDA officials launched an investigation of largely anecdotal reports suggesting a link between the drug and suicidal thoughts and behaviors. The investigation was expected to take nine months.

ALA Chief Medical Officer Norman Edelman, MD, says the new analysis should reassure the millions of people who take Singulair.

"I think there is good evidence that Singulair does not cause depression," he tells WebMD. "We can't say this with absolute certainty, but this goes a long way toward answering the question."

The analysis will be presented in a letter to be published in an upcoming issue of the Journal of Allergy and Clinical Immunology.

Researchers Janet Holbrook, PhD, and Raida Harik-Khan, PhD, combined data from the three ALA-funded trials conducted at 20 research centers across the country.

The original aim of the studies, which included children and adults, was to determine how best to manage asthma symptoms with available treatments, Edelman says. But the studies also included quality of life and emotional well-being assessments for 536 patients treated with Singulair and 816 patients who did not take Singulair.

Adults in the studies were followed for two to 24 weeks and the children were followed for four to 16 weeks.

There were no reports of psychiatric problems, depressive episodes, or suicide among any of the study participants who took Singulair.

None of the trials showed evidence of significant deterioration of emotional well-being in adults or children who took the drug. Compared to people who didn't take the drug, Singulair users showed more improvement in emotional well-being after two weeks of treatment in one trial, but the difference did not last.

"These findings lead us to conclude that despite the recent publicity regarding the adverse effects of (Singulair) on suicide or emotional well-being, we did not find evidence to suggest that this is a general concern," the researchers write.

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