FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Previous Volume 351:1385-1387 September 30, 2004 Number 14 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 Purchase this article Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article by Bennett, C. L. PubMed Citation

When a new drug is first marketed, findings regarding its efficacy and safety are commonly based on the experience of several thousand people who have been treated in controlled clinical trials. Despite extensive testing, rare adverse events (those that occur in less than one patient per thousand) can easily escape detection, and unforeseen interactions with coexisting clinical conditions or other drug therapies may remain unexplored. As a result, the characterization of the full safety profile of a new drug relies heavily on clinicians' careful observation of its effects in "real world" practice that is far removed from clinical-trial conditions. Discovery . . . [Full Text of this Article]

Source Information

From the Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Md.

This article has been cited by other articles:

• Bennett, C. L., Nebeker, J. R., Yarnold, P. R., Tigue, C. C., Dorr, D. A., McKoy, J. M., Edwards, B. J., Hurdle, J. F., West, D. P., Lau, D. T., Angelotta, C., Weitzman, S. A., Belknap, S. M., Djulbegovic, B., Tallman, M. S., Kuzel, T. M., Benson, A. B., Evens, A., Trifilio, S. M., Courtney, D. M., Raisch, D. W. (2007). Evaluation of Serious Adverse Drug Reactions: A Proactive Pharmacovigilance Program (RADAR) vs Safety Activities Conducted by the Food and Drug Administration and Pharmaceutical Manufacturers. Arch Intern Med 167: 1041-1049 [Abstract] [Full Text]  
• Ridley, D. B., Kramer, J. M., Tilson, H. H., Grabowski, H. G., Schulman, K. A. (2006). Spending on postapproval drug safety.. Health Aff (Millwood) 25: 429-436 [Abstract] [Full Text]  
• Digman, C., Klein, A. K., Pittas, A. G. (2005). Leukopenia and Thrombocytopenia Caused by Thiazolidinediones. ANN INTERN MED 143: 465-466 [Full Text]  
• Bennett, C. L., Nebeker, J. R., Raisch, D. W. (2005). The RADAR Project and the FDA--Reply. JAMA 294: 1206-1207 [Full Text]  
• Gottlieb, S. (2005). Opening Pandora's Pillbox: Using Modern Information Tools To Improve Drug Safety. Health Aff (Millwood) 24: 938-948 [Abstract] [Full Text]  
• Bennett, C. L., Nebeker, J. R., Lyons, E. A., Samore, M. H., Feldman, M. D., McKoy, J. M., Carson, K. R., Belknap, S. M., Trifilio, S. M., Schumock, G. T., Yarnold, P. R., Davidson, C. J., Evens, A. M., Kuzel, T. M., Parada, J. P., Cournoyer, D., West, D. P., Sartor, O., Tallman, M. S., Raisch, D. W. (2005). The Research on Adverse Drug Events and Reports (RADAR) Project. JAMA 293: 2131-2140 [Abstract] [Full Text]  
• Hauben, M., Reich, L. (2005). Potential Utility of Data-Mining Algorithms for Early Detection of Potentially Fatal/Disabling Adverse Drug Reactions: A Retrospective Evaluation. J Clin Pharmacol 45: 378-384 [Abstract] [Full Text]  
• Slater, E. E. (2005). Today's FDA. NEJM 352: 293-297 [Full Text]