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Previous Volume 349:474-485 July 31, 2003 Number 5 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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In the past five years, two drugs have been withdrawn from the market by the Food and Drug Administration (FDA) for causing severe liver injury, a potential danger that had not been fully recognized in the course of the preapproval clinical trials. Reports of adverse drug reactions of any type engender fear and skepticism in the public about the actions of the pharmaceutical industry and the FDA.¹ Drug-induced hepatic injury is the most frequent reason cited for the withdrawal from the market of an approved drug, and it also accounts for more than 50 percent of the cases of acute . . . [Full Text of this Article]

Hepatic Biotransformation

Types of Drug Reactions

Targets of Cell Injury

Pathogenesis

Clinical Consequences

Idiosyncratic Reactions

Allergic Reactions

Bile-Duct Injury

Dose-Related Acetaminophen Toxicity

Less Common Drug Reactions

Diagnosis and Treatment of Drug Reactions

Hepatotoxicity in Patients with Chronic Liver Disease

The Process of Drug Approval

Drugs Recently Withdrawn from the Market

Approach to New Drugs

Source Information

From the Division of Digestive and Liver Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas.

Address reprint requests to Dr. Lee at the Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9151, or at william.lee@utsouthwestern.edu.

Related Letters:

Drug-Induced Hepatotoxicity
Juurlink D. N., Andrade R. J., Lucena M. I., Andres E., Manfredini R., Boari B., Gallerani M., Lee W. M.
Extract | Full Text | PDF  
N Engl J Med 2003; 349:1974-1976, Nov 13, 2003. Correspondence

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