Brief update on Singulair-suicide link

Merck issued a press release today responding to the FDA’s investigation. Along with the standard "we didn’t know about this problem until after it the market" disclaimer, the PR mentioned:

In a cumulative analysis recently provided to the FDA of Merck’s randomized, double-blind, placebo-controlled clinical trials, which included over 11,000 adults and children in over 40 studies who were treated with SINGULAIR, there were no reports of suicidal thoughts or actions and no completed suicides in the patients who received SINGULAIR.

Additionally, in a cumulative analysis recently provided to the FDA of Merck’s randomized, double-blind, clinical trials that compared SINGULAIR with other active agents to treat asthma (which included over 3,900 adults and children who were treated with SINGULAIR and over 3,400 who were treated with other asthma therapies), there was 1 patient who attempted suicide who received SINGULAIR, and there were 3 patients who attempted suicide who received other asthma therapies (including inhaled corticosteroids and long-acting beta-agonists).  These studies were not designed to compare the rate of suicide in patients taking SINGULAIR with the rate of suicide in patients taking these other asthma agents.

Did Merck report that one suicidal attempt when compared to "other active agents to treat asthma"? It doesn’t say anything in their patient safety or prescribing information when I checked. Perhaps someone can find out whether they reported this in their clinical trials?

In the meantime, the Singulair section of medications.com is ablaze with parents who are now expressing concern over their children’s well-being on the drug. Apparently, issues have cropped up with the drug even before the FDA announced their investigation.

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3 Comments

  1. Jenna said,

    January 7, 2009 at 6:09 pm

    This article:
    http://www.healthday.com/Article.asp?AID=613968
    states that in clinical trials that compared Singulair with other active agents to treat asthma,there was one patient who attempted suicide who received Singulair, and there were three patients who attempted suicide who received other asthma therapies [including inhaled corticosteroids and long-acting beta-agonists].
    Although I keep reading on the internet that depression was not seen as a side effect in the clinical trials, depression WAS reported in patients taking montelukast in the clinical trials.
    This is a link to the FDA Medical Review for Singulair: http://www.fda.gov/cder/foi/nda/98/020829s000_Singular_Medr.pdf
    On page 78 of the document (p. 84 of the PDF)is a table listing reasons why participants dropped out of the clinical trials. One patient in the montelukast group (out of 795) in this part of the clinical trials is listed with depression as an adverse experience and the notation reads “discontinued due to adverse experiences considered drug related by the investigator.”
    On page 80 on the document, which is page 86 of the PDF: Depression was identified in patients taking Montelukast in the clinical trials at a slightly higher rate than placebo (0.6% vs. 0.4%).

  2. Jenna said,

    January 7, 2009 at 9:52 pm

    Additionally to answer your question, one suicide attempt was listed in the medical review in the list of participants who withdrew from the trial due to adverse experiences.

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