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Adverse Drug Reactions: A Perspective J. Christopher Spell, Ph.D. Global Medical Affairs Wyeth Pharmaceuticals Presentation Outline From the Headlines! What is an adverse drug reaction (ADR) Types and Classification of ADRs Risk Factors for ADRs and Examples Regulations and the FDA: History, Background, and Postmarketing Surveillance Specific ADR Cases Future/Conclusions From The Headlines!! From The Headlines!! The Perceptions and Implications……….. Adverse drug reactions have had significant media exposure, with the resulting impact on the public at large. Pharmaceutical companies have felt the pinch of mismanagement of high-profile ADR reports that have effected the industry. Patient care may suffer or they may lose confidence in a drug (especially in the case of recall). The Reports and Findings……….. A meta-analysis of 39 studies found an inhospital incidence of ADRs of 6.7%, and an incidence of fatal ADRs of 0.3%. This makes fatal ADRs amongst the top six leading causes of death in the United States 30% to 60% are preventable ADRs may lead to an additional $1.56 to $4 billion in direct hospital costs per year in the United States Adverse Drug Reactions: What are they? An injury resulting from medical intervention related to a drug Any noxious and unintended effect of drug that occurs at doses used in human for prophylaxis, diagnosis, or treatment WHO definition Excludes therapeutic failures, overdose, drug abuse, noncompliance, and medication errors Majority of ADRs are caused by predictable, nonimmunologic effects (75 to 80 percent) Relationship Between ADEs and ADRs Adverse Drug Reactions: How do we learn about them? Most common adverse reactions are detected in premarketing clinical trials (reported in prescribing information) However, most clinical trials are of short duration, and patient numbers in trials are low compared to population Latent ADRs often missed 3000 patients at risk needed to detect with an incidence rate of 1/1000 with 95% certainty Mo