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March 13, 2009

Media Inquiries:
Karen Riley, 301-796-4674
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FDA Launches SAFEKIDS Initiative with Academic and Clinical Partners
Public-Private Partnership will assess safety of anesthetics and sedatives in young children

The U.S. Food and Drug Administration today announced agreements with five partners to study the effects of anesthetics and sedatives on the neurocognitive development of infants and young children.

The Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Initiative is a multi-year project designed to address major gaps in scientific information about the safe use of anesthetics and sedatives received by millions of children each year.

"The long-term benefits of these studies will inform risk-benefit decisions that both anesthesiologists and parents must make when considering the choice of anesthesia in pediatric patients," said FDA Acting Commissioner Frank M. Torti, M.D., M.P.H.

Research by the FDA's National Center for Toxicological Research using juvenile animal models shows that exposure to some anesthetics and sedatives is associated with memory and learning deficits and other neurodegenerative changes in the central nervous system. Insufficient human data exists to either support or refute the possibility that similar effects could occur in children. The SAFEKIDS Initiative will develop this data.

The FDA's research partners in the SAFEKIDS Initiative include:

  • The International Anesthesia Research Society (Cleveland, Ohio), which will be responsible for leading the administrative oversight and the overarching framework for the partnership.
  • Children's Hospital - Harvard University (Boston), which is conducting a long-term study of neurodevelopmental outcomes in pediatric patients administered regional or general anesthesia as neonates or infants.
  • Arkansas Children's Hospital Research Institute (Little Rock, Ark.), which will research the pharmacokinetics, pharmacodynamics, and neurotoxic effects of an anesthetic agent in infants undergoing various surgical procedures.
  • Columbia University (New York), which will evaluate the effects of anesthetic exposure on neurocognitive, emotional and behavioral outcomes in pediatric patients
  • Mayo Clinic (Rochester, Minn.), which will study long-term cognitive development following exposure to general anesthetic agents during infancy.

In addition, NCTR will conduct non-clinical studies in non-human primates to assess the decline in mental function when young animals are exposed to anesthesia and to develop noninvasive ways of using imaging to measure structural changes in the brain.

Under the framework of the SAFEKIDS Initiative, the FDA and the International Anesthesia Research Society will develop a public-private partnership that will support additional research in this area.

The FDA expects the first results from the SAFEKIDS Initiative will be available within two years.



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