At the request of the Pharmacovigilance Department of the Italian Drug Agency (AIFA), the sponsor (Johnson & Johnson) performed two post-marketing analyses of QT interval prolongation and TdP with haloperidol administration (oral or injectable). In one analysis, the sponsor searched their Benefit Risk Management worldwide safety database for QT prolongation -related adverse event reports received through June 30, 2005. This search identified 229 reports, many of which the sponsor described as confounded by concomitant QT-prolonging drugs or medical conditions. The reports included 73 cases of TdP, eleven of which were fatal. Eight of the eleven fatal cases involved intravenous administration of various doses of haloperidol.