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Previous Volume 355:2171-2173 November 23, 2006 Number 21 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.

	Full Text PDF PDA Full Text Perspective by Avorn, J. Editorial by Drazen, J. M. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

The full safety profile of a new drug is rarely known at the time of approval by the Food and Drug Administration (FDA). Most drug-development programs designed for treatments of symptomatic indications are underpowered to detect any increased risk of rare drug reactions or change in background event rates attributable to the drug. Large, post-marketing, randomized, controlled trials provide robust data on drug safety but may be subject to multiple sources of bias. Observational studies of a drug's effects in clinical practice can offer additional information on risks. The recent discussions of aprotinin (Trasylol, Bayer) by the Cardiovascular and Renal . . . [Full Text of this Article]

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Dr. Hiatt is a professor of medicine at the University of Colorado School of Medicine and president of the Colorado Prevention Center — both in Denver — and is the current chair of the Cardiovascular and Renal Drugs Advisory Committee of the FDA. Opinions expressed in this article are those of the author and do not necessarily reflect the opinions of the FDA or the advisory committee.

Related Letters:

Judging the Safety of Aprotinin
Mangano D. T., Rieves R. D., Weiss K. D.
Extract | Full Text | PDF  
N Engl J Med 2006; 355:2261-2262, Nov 23, 2006. Correspondence

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