Drug–Drug Interactions: Communicating Post-market Drug Safety Information in the USA



It has been more than a decade since the withdrawal of a number of drugs from the market as a result of serious adverse events from drug–drug interactions (DDI). Since then, additional research has led to a much better understanding of the mechanisms behind many of these interactions. These advances have made DDI one of the best understood causes of observed adverse drug events. However, to reap the full benefit of all this research, much more could be done to translate this information into a form more useful in clinical care settings. Health-care providers rely on two principal sources – FDA approved product information (i.e., drug product label) and drug interaction databases – to help them prescribe medications safely. Greater standardization of definitions, classifications, and severity assessments of drug interactions would help prescribers to better understand the clinical significance of a particular DDI. Achieving greater standardization will require the continued input and coordination of efforts of important stake holders such as academic scientists, industry, and regulators.


Drug Interaction Product Information Stake Holder Medication Guide Patient Medication History 
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© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  1. 1.Novartis Pharmaceuticals Corporation (SM)East HanoverUSA
  2. 2.Department of Clinical PharmacologyGlobal Alliance for TB Drug DevelopmentNew YorkUSA

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