Citation

Philip G, Hustad C, Noonan G, Malice MP, Ezekowitz A, Reiss TF, Knorr B. J. Allergy Clin. Immunol. 2009; 124(4): 691-6.e6.

Affiliation

Merck & Co, Inc, North Wales, Pa. 19454, USA. george_philip@merck.com

Comment In:

J Allergy Clin Immunol 2009;124(4):697-8

Copyright

(Copyright © 2009, Elsevier Publishing)

DOI

10.1016/j.jaci.2009.08.010

PMID

19815114

Abstract

BACKGROUND: In recent years, a number of drugs and drug classes have come under scrutiny by the US Food and Drug Administration regarding suicidality (including suicidal behavior and ideation). OBJECTIVE: We sought to perform 2 reviews (requested by the US Food and Drug Administration) of the number of events possibly related to suicidality reported in Merck clinical trials of montelukast. METHODS: Method 1 was a descriptive review of clinical adverse experiences (AEs) from 116 studies (double-blind and open-label, adult and pediatric, and single- and multiple-dose studies) completed as of March 2008. Summaries were constructed from investigator-reported AE terms possibly related to suicidality (completed suicide, suicide attempt, and suicidal ideation) or self-injurious behavior. Method 2 used a retrospective adjudication of investigator-reported AEs and other events listed in the study database described as possibly suicidality-related adverse events (PSRAEs) in a prespecified set of 41 double-blind, placebo-controlled trials completed as of April 2008. RESULTS: No completed suicides were reported in any study. For the descriptive review, 20,131 adults and children received montelukast, 9,287 received placebo, and 8,346 received active control; AEs possibly related to suicidality were rare and were similar between the montelukast and placebo or active-control groups. For the adjudicated review across 22,433 patients, there were 730 adjudicated events. In 9,929 patients taking montelukast, 1 PSRAE was identified (classified as suicidal ideation); none were identified in 7,780 and 4,724 patients taking placebo and active control, respectively. CONCLUSIONS: Assessed by using 2 complementary methods, there were no reports of completed suicide, and reports of PSRAEs were rare in patients receiving montelukast and similar to those seen in control subjects.

Language: en