Pharmacovigilance for evaluating adverse drug reactions: value, organization, and methods,10.1016/j.jbspin.2006.09.002,Joint Bone Spine,Jean-Louis Mon

• ...The pharmacovigilance databases were developed in order to follow the safety of drugs after their administrative approval and allow rapid detection of new and/or unexpected ADRs [12]...
• ...All suspected ADRs are registered in the French Pharmacovigilance Database [12]...
• ...According to WHO definition [12, 18], all reports resulting in death, leading to hospitalization or prolongation of hospitalization, persistent or significant disability, incapacity, or being life threatening are considered as “serious”...
• ...The differences between our results and the other analyses could be explained, at least partly, by the relatively high level of spontaneous reporting of ADRs in France in comparison with other countries [12]...

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