Was the thrombotic risk of rofecoxib predictable from the French Pharmacovigilance Database before 30 September 2004?
Despite the compulsory limits of the case/noncase methodology, this study found an association between rofecoxib exposure and the occurrence of "serious" thrombotic ADRs as early as the end of the first year of rofecoxib marketing in France. The association between celecoxib and the occurrence of such ADRs appears less clear. Our work also shows the potential use of careful analysis of pharmacovigilance databases (investigating, for example, cumulative values of risk) in the early identification of new ADRs.
The present study suggests that a single session of RE activates the endocannabinoid system to induce antinociception.