The Association Between Leukotriene-Modifying Agents and Suicidality: A Review of Literature

In 2008 Food and Drug Administration issued a warning regarding a possible association between leukotriene-modifying agents and suicidality.

The warning remains controversial and this review of literature is an attempt to examine the evidence on the matter.

Literature search on PubMed.

The data supporting a relationship between leukotriene-modifying agents and suicidality comes primarily from reviews of individual safety reports in adverse event databases; it is subject to considerable reporting bias and does not control for confounding factors. Case-control and cohort studies as well as data from clinical trials do not support an association between leukotriene-modifying agents and suicidality. The data from ecological studies offers strong evidence of a lack of positive association between leukotriene-modifying agents and suicide outcomes (attempts and deaths) at the population level. Furthermore, there is no pharmacological mechanism that would explain an association between the two.

Overall, the weight of higher quality evidence casts doubt on the association (especially at population level), but is not enough to conclusively disprove the association at an individual level.