Impact of safetyrelated regulatory action on clinical practice: A systematic review. Drug Safety

Abstract Background: After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare pro-fessionals. However, the effectiveness of these safety-related regulatory ac-tions is under question. We currently lack a comprehensive overview of the effects of these drug safety warnings on clinical practice to resolve the debate about their effectiveness. Objective: The aim of this systematic review is to provide an overview of studies that assessed the impact of safety warnings. Study Selection: A systematic search was performed for articles assessing the impact of Direct Healthcare Professional Communications or ‘Dear Doctor’ letters, Black Box Warnings and Public Health Advisories on clinical behav-iour published between January 1996 and January 2010. The following variables were extracted: publication year, country, name of the drug, safety issue, specific safety warning (Direct Healthcare Professional Communication/ Black Box Warning/Public Health Advisory), effect (intended/unintended) o