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KMID : 1011320140070010017
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Journal of Pharmacoepidemiology and Risk Management
2014 Volume.7 No. 1 p.17 ~ p.27
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Change in Drug Safety Management by U.S. FDA after Rofecoxib Safety Issue
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Choi Eun-Mi
Jung Hyun-Joo
Jung Sun-Young
Park Byung-Joo
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Abstract
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Despite rigorous pre-marketing drug evaluation processes, safety issues about unsuspected adverse drug reactions are often raised in the post marketing phase. A notable example is a ‘rofecoxib’; pharmacoepidemiological studies confirmed that there was an association between the use of rofecoxib and the risk of cardiovascular events. After the withdrawal of rofecoxib from the market. In response to growing public concerns with the health threat posed by approved drugs, the U.S. Food and Drug Administration (FDA) asked the Institute of Medicine (IOM) to assess the post marketing surveillance system and provide how FDA can improve their drug safety management system. On September 2006, the IOM released a report entitled “The Future of Drug Safety - Promoting and Protecting the Health of the Public”. This report offered the suggestions to reinforce the FDA’s drug safety management program. In response to the IOM report, the FDA released a statement entitled “The FDA’s responses” in 2007 that included a plan of action to address the recommendations in the report. To transform drug safety system, the FDA planed to strengthen methods and tools of safety surveillance through the implementation of ‘Sentinel Initiative’ and issuing guidance on epidemiology best practices. As a result, FDA has operated the Mini- Sentinel and Observational Medical Outcomes Partnership (OMOP) from 2009 and developed a guideline for the Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data in 2013. This review provides us with the insight on the US FDA’s recent changes in drug safety management system after the rofecoxib safety issue.
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KEYWORD
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Drug safety management, Pharmacoepidemiology, Rofecoxib
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