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Raschi et al. [1] extracted torsade de pointes–related events from three national spontaneous reporting systems (SRSs) and found five potential signals undetected in the US Food and Drug Administration (FDA) Adverse Event Reporting System. However, they should also have highlighted what signals they did not find. Indeed, the absence of reports for citalopram or escitalopram and for thioridazine (which was withdrawn from the market worldwide only in 2005) is surprising, as they should rank among the top ones [2, 3]. Similarly, in an analysis of drug-induced pancreatitis, using the French SRS, the lack of a report for amiodarone was unnoticed despite this drug being widely used and its imputability being well evidence based [4–6]. Such ‘no findings’ are an opportunity to call, once more, for raising the bar for drug safety. This needs a comprehensive framework: better education and training, incentives for reporting, selective reports versus exhaustive reporting (e.g. seriousness, drug class and timeframe) and access to electronic health records (disease, hospitalization and prescriptions) for researchers, etc. The list is long and not new, as is the inertia of the system.

Comment on ‘The Contribution of National Spontaneous Reporting Systems to Detect Signals of Torsadogenicity: Issues Emerging from the ARITMO Project’