Montelukast sodium ( Singulair ), a leukotriene-receptor antagonist, is indicated for the prophylaxis and chronic treatment of asthma in patients 2 years of age and older. It is also indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older when other treatments are not effective or not tolerated.

Montelukast has been marketed in Canada since 1997.

Between September 2007 and July 2008, updates were made to the Adverse drug reactions section of the Canadian product monograph for Montelukast to include depression, suicidality and anxiousness.
The American product monograph was similarly updated.

In March 2008, the FDA ( Food and Drug Administration ) issued an Early communication stating that it was investigating further the suspected association between Montelukast and suicidality.
Following the FDA's early communication, there was a 7-fold increase in the number of Montelukast-related cases reported to the Adverse Event Reporting System ( AERS ) database in the United States.

From the date of marketing to Jan. 31, 2009, Health Canada received 13 adverse reaction reports related to suicidality or self-injury suspected of being associated with the use of Montelukast.
Eight reports stated that the reaction abated after the dose was reduced or the drug was stopped. The reaction reappeared after the reintroduction of Montelukast in 1 case.

From the date of marketing to Jan. 31, 2009, Health Canada received 29 other adverse reaction reports relating to depression, hostility or psychosis suspected of being associated with the use of Montelukast . In 19 cases, the reaction abated after Montelukast was stopped or the dose was reduced. The reaction reappeared after the reintroduction of Montelukast in 4 cases.

No deaths were reported in any of the cases discussed above. Twenty-six of the 42 reports involved patients under 18 years of age ( age was not indicated in 5 reports ).

Source: Health Canada, 2009

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