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The study of the grounds on which data regulatory authorities base their decisions on drug safety evaluations is an important clinical and public health issue. The aim of this study was to review the type and publication status of data sources supporting benefit/risk ratio re-evaluations conducted by the major regulatory authorities on safety issues.

A website search was carried out to identify all safety alerts published by the U.S Food and Drugs Administration, Health Canada, European Medicines Agency and the Australian Therapeutics Goods Administration. Safety alerts were included if the causal relation between a suspected drug exposure and the occurrence of an adverse event was evaluated for the first time between 2010 and 2012. Type of data sources evaluated by these regulatory authorities, publication status of the data sources …