Response to “Evaluating Adverse Events in Databases”

First of all, they cite randomized placebo-controlled clinical trials, only to then consider them impracticable, due to the necessary time and resources. On the basis of the weakness points of all the methods, shared also in the commentary, it is possible to argue that at the moment in pharmacovigilance does not exist a methodological approach free of limitations to draw definitive conclusions. [...]our conclusions cannot be considered as “definitive,” being accompanied by an examination of the limitations associated with the spontaneous reporting databases. [...]we conclude this response reiterating that, despite known limitations, spontaneous reporting of adverse reactions is the cornerstone of pharmacovigilance that still today helps us to face address safety concerns after drug authorization.