title: Does proof of casualty ever exist in pharmacovigilance?
abstract: 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 casualty 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.
authors.affiliation: Department of Postmarketing Surveillance, Pasteur Mérieux Serums and Vaccines, Lyon, France.
authors.forename: M
authors.initials: M
authors.lastname: Auriche
authors.forename: E
authors.initials: E
authors.lastname: Loupi
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D015984:Causality; D004812:Epidemiologic Methods; D006801:Humans; D011358:Product Surveillance, Postmarketing; D012107:Research Design