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Commentary

Nature 446, 975-977 (26 April 2007) | doi:10.1038/446975a; Published online 25 April 2007

When good drugs go bad

Kathleen M. Giacomini1, Ronald M. Krauss2, Dan M. Roden3, Michel Eichelbaum4, Michael R. Hayden5 & Yusuke Nakamura6

  1. Kathleen M. Giacomini is in the Department of Biopharmaceutical Sciences, University of California, San Francisco
  2. Ronald M. Krauss is at the Childrens Hospital Oakland Research Institute
  3. Dan M. Roden is at the Vanderbilt University School of Medicine
  4. Michel Eichelbaum is at the Stuttgart Institut Klinische Pharmakologie
  5. Michael R. Hayden is at the University of British Columbia
  6. Yusuke Nakamura is at the University of Tokyo.

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How can we best reduce the risk of severe adverse reactions to marketed drugs? An international group of scientists argues that a global research network is needed to identify genetically at-risk populations.

Safety issues can arise throughout the life-history of a drug — from preclinical screening through to clinical trials and, importantly, after the drug is marketed and tested for the first time on the population at large1. Although serious adverse drug reactions (SADRs) that can cause fatalities or severe morbidity are relatively rare once a drug is marketed, they are estimated to be the fourth leading cause of death in the United States, not far behind cancer and heart disease2.

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