Published Online: Thursday, November 1, 2007

The newly formed International Serious Adverse Events Consortium (SAEC) plans to launch 2 initial research programs designed to identify genetic markers that may help predict which individuals are at risk for serious drug-related adverse events.

The studies will address drug-related liver toxicity and the rare but serious drug-related skin condition Stevens-Johnson syndrome. Patients respond differently to medicines, and all medicines can have side effects in some individuals.

The SAEC's work is based on the hypothesis that these differences have a genetic basis, and its research studies will examine the impact genes can have on how individuals respond to drugs. The findings will be made available to the research community for further study. The groups' objectives are as follows:

  • Reduce the significant patient and economic costs associated with drug-related SAEs
  • Improve the flow of safe and effective medical advances by addressing safety issues regarding new drugs before they enter the marketplace
  • Establish common pharmacogenetic research platforms for SAEC members and other academic institutions to determine relationships between genetic variations and SAEs
  • Encourage further study by creating a public database SAEC is a nonprofit partnership comprised of leading pharmaceutical companies, academic institutions, and the FDA.

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