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
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
"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.