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[U.S. Food and
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The Clinical Impact of Adverse Event Reporting

The Food and Drug Administration (FDA)'s monitoring of the continued safety of marketed medical products depends greatly upon reporting of adverse events by health professionals. An understanding of how FDA uses this information, and of the limitations/strengths of the national postmarketing surveillance system, underscores the importance of this professional responsibility to the public health.

A MEDWATCH Continuing Education Article
October 1996

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Table of Contents

Learning Objectives


The Need for Postmarketing Surveillance

Premarketing Animal Studies

Premarketing Human Clinical Studies

Postmarketing Experience


TABLE 1. What is a Serious Event?

Postmarketing Reporting of Adverse Events

By Health Professionals

By Hospitals

Reporting Required By Law or Regulation

TABLE 2. Medical Device Reporting (MDR) Requirements

TABLE 3. Adverse Event (AE) Reporting Requirements for Pharmaceuticals

Limitations and Strengths of Spontaneous Reports Data


Adverse Event Recognition



Estimation of Population Exposure

Report Quality


Large-Scale and Cost- Effective

Generation of Hypotheses and Signals

TABLE 4. Useful Factors for Assessing Causal Relationship Between Drug and Reported Adverse Event

Clinician Contribution

FDA Evaluation of Reports of Adverse Events

Dissemination of Safety-Related Information

TABLE 5. Examples of Safety-Related FDA Notifications


Clinical Synopses:

  1. Biologics:
      Intravenous Immunoglobulin and Aseptic Meningitis Syndrome

  2. Medical Devices:
      Barium Enema Kits and Sudden Death

  3. Special Nutritionals:
      L-tryptophan Related Eosinophilia-Myalgia Syndrome

  4. Drugs:
      Temafloxacin and Hemolytic Anemia



Self Assessment Questions

Application for Continuing Education Credit

Provided as a service by the Staff College, Center for Drug
Evaluation and Research, Food and Drug Administration

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