Summary
Identifying the adverse effects of drugs, thus transforming adverse events into adverse drug reactions, is a useful and necessary but complicated task. Objective proof of a causal relationship between a drug and a specific event is quite exceptional. In most cases, this relationship remains subjective and is no more than inner conviction.
Several means are at our disposal to achieve causal assessment: spontaneous reporting, clinical trials, cohorts with and without controls, and case-control studies, with each having advantages and limitations. The search for causality in pharmacovigilance is a necessary scientific goal, but a high degree of suspicion may be all that is necessary to withdraw a drug from the market if it is suspected of causing serious adverse effects.
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Auriche, M., Loupi, E. Does Proof of Causality Ever Exist in Pharmacovigilance?. Drug-Safety 9, 230–235 (1993). https://doi.org/10.2165/00002018-199309030-00008
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DOI: https://doi.org/10.2165/00002018-199309030-00008