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NIH halts use of COX-2 inhibitor in large cancer prevention trial

are working closely with our colleagues at FDA to ensure that the public has the information they need to make informed decisions about the use of this class of drug."

"The rigor of our clinical trials system has allowed us to find this problem," said NCI Director Andrew C. von Eschenbach, M.D. "We have a strong system that provides us with the opportunity to both find ways to effectively treat and prevent disease and to do so in a way that protects the lives and safety of the participants."

NIH sponsors over 40 studies using celecoxib for the prevention and treatment of cancer, dementia and other diseases. In light of these new findings, NIH Director Zerhouni requested:

  • a full review of all NIH-supported studies involving this class of drug.
  • NIH Institutes to inform the principal investigators for all of these studies and will ask them to communicate directly with their study participants and explain the risks and benefits
  • NIH to ask each investigator to inform us of the their plan to analyze their data in light of the information
  • the Institutional Review Boards (IRBs) for all related trials to assess the new information and to conduct a safety review as well


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Contact: John Burklow / Don Ralbovsky
301-496-5787
NIH/Office of the Director
17-Dec-2004


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