BACKGROUND: In 2008 Food and Drug Administration issued a warning regarding a possible association between leukotriene-modifying agents and suicidality.
OBJECTIVE: The warning remains controversial and this review of literature is an attempt to examine the evidence on the matter.
METHODS: Literature search on PubMed.
RESULTS: 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.
CONCLUSION: 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.