Analysis Shows No Singulair, Suicide Link
Study Suggests Early Improvement in Emotional Well-Being
Findings 'Reassuring' continued...
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.
Drugmaker: Findings No Surprise
Merck spokesman Ian McConnell says the finding comes as no surprise.
"This independent study adds further support to the large body of evidence for the safety of Singulair," he tells WebMD.
Late in March, after the FDA investigation was announced, Merck senior director of clinical research George Philip, MD, told WebMD that there were no reports of suicides in 40 clinical studies involving 11,000 patients who took Singulair.
Singulair belongs to a class of drugs called leukotriene receptor antagonists. The FDA is reviewing post-marketing data on other drugs in the class to determine if further investigation is warranted.
Two of the nation's largest asthma organizations also weighed in on the Singulair-suicide issue after the FDA investigation was announced.
"There are no data from well-designed studies to indicate a link between Singulair and suicide," officials with the American College of Allergy, Asthma and Immunology and the American Academy of Allergy, Asthma and Immunology noted in a joint statement.
"The concern expressed by the FDA is based entirely on case reports and there is no indication that such effects apply to other leukotriene-modifying medications."
The ACAAI and AAAAI statement further noted that, "based on the information currently available, patients taking Singulair should continue to take the medication as prescribed provided 1): the patient and physician feel the medication is effective; and 2) the patient does not experience any suicidal behavior or thoughts."