Abstract

“We shouldn’t overload the disproportionality methods; putting them in perspective will provide the maximum benefit.”



A drug safety signal is not necessarily entirely new information about a potential drug safety hazard, it can be additional information (either quantitative or qualitative) about a previously known drug/event association: for example, new information about a risk factor for an adverse drug reaction (ADR), a sub-population being at an increased risk of developing an ADR or information about a dose-effect relationship for an ADR.