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Volume 356:1601-1604 April 19, 2007 Number 16 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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Three years ago, the Food and Drug Administration (FDA) approved the drug Ketek (telithromycin), lauding it as the first of a new class of antimicrobial agents that circumvent antibiotic resistance. Since then, Ketek has been linked to dozens of cases of severe liver injury, been the subject of a series of increasingly urgent safety warnings, and sparked two Congressional investigations of the FDA's acceptance of fraudulent safety data and inappropriate trial methods when it reviewed the drug for approval. As a former FDA physician who was involved in the Ketek review, I believe there are lessons to be learned from . . . [Full Text of this Article]

Source Information

Dr. Ross is a clinical assistant professor at George Washington University School of Medicine and Health Sciences, Washington, D.C.

An interview with Dr. Ross can be heard at www.nejm.org. A letter to the editor from Soreth and colleagues at the FDA appears on page 1675.

Related Letters:

Ketek — The FDA Perspective
Soreth J., Cox E., Kweder S., Jenkins J., Galson S.
Extract | Full Text | PDF  
N Engl J Med 2007; 356:1675-1676, Apr 19, 2007. Correspondence

This article has been cited by other articles:

• Chen, Y., Guo, J. J, Healy, D. P, Lin, X., Patel, N. C (2008). Risk of Hepatotoxicity Associated with the Use of Telithromycin: A Signal Detection Using Data Mining Algorithms. The Annals of Pharmacotherapy 42: 1791-1796 [Abstract] [Full Text]  
• Xu, J. J., Henstock, P. V., Dunn, M. C., Smith, A. R., Chabot, J. R., de Graaf, D. (2008). Cellular Imaging Predictions of Clinical Drug-Induced Liver Injury. Toxicol Sci 105: 97-105 [Abstract] [Full Text]  
• van Thiel, G. J M W, van Delden, J. J M (2008). Phase IV research: innovation in need of ethics. J. Med. Ethics 34: 415-416 [Full Text]  
• Carpenter, D., Zucker, E. J., Avorn, J. (2008). Drug-Review Deadlines and Safety Problems. NEJM 358: 1354-1361 [Abstract] [Full Text]  
• Bolesta, S., Roslund, B. P. (2008). Elevated hepatic transaminases associated with telithromycin therapy: A case report and literature review. Am J Health Syst Pharm 65: 37-41 [Abstract] [Full Text]  
• Soreth, J., Cox, E., Kweder, S., Jenkins, J., Galson, S. (2007). Ketek -- The FDA Perspective. NEJM 356: 1675-1676 [Full Text]