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.