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    FDA Announces Program to Study Anesthesia Risks in Children

    By Jennifer Huddleston, staff writer     

    The U.S. Food and Drug Administration (FDA) has initiated a research program to investigate the effects of anesthesia on developing brains.

    Safety of Key Inhaled and Intravenous Drugs in Pediatrics program, called SAFEKIDS, was created after the FDA’s Anesthesia and Life-Support Drugs advisory committee in March 2007 first publicly and officially questioned the link between anesthesia and adverse effects on the developing brain. [1]

    The FDA has engaged five anesthesiology groups and universities, including the International Anesthesia Research Society (IARS), Children’s Hospital Boston at Harvard University, Arkansas Children’s Hospital Research Institute, Columbia University and the Mayo Clinic, to participate in the project and conduct various studies.

    "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," Frank M. Torti, M.D., M.P.H., FDA acting commissioner, said in an FDA news release. [2]

    The program’s findings could prompt pharmaceutical companies to add warnings about cognitive risks for young patients to the labels of certain anesthetic drugs, said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products at the FDA Center for Drug Evaluation. [3]

    Previous animal studies have shown that some anesthetics can harm neurons in the brain. While recent studies in humans have suggested a link between anesthesia exposure in early life and later developmental problems, there currently is no concrete evidence to support or disprove that possibility. The SAFEKIDS program is intended to help gather such data.

    Some physicians predict that in the meantime, coverage of the issue is likely to continue to cause worry among all parties.

    “I think studying outcomes is the right thing to do, but I’m amazed, frankly, at how quickly this thing caught on fire,” said Gregory Crosby, M.D., president-elect of the Society of Neurosurgical Anesthesia and Critical Care and an associate professor of anesthesia at Brigham and Women’s Hospital and Harvard Medical School in Boston. “After all, what we have is a smoking gun but no victim. In the setting of surgical illness, clinical outcome studies will be hard-pressed to assign any adverse effect to anesthesia itself. Also, given the incredible plasticity and capacity for recovery of the developing brain, I’m a little concerned that the hype is overblown and that patients, parents and physicians will get scared unnecessarily.” [4]

    According to Rappaport, the SAFEKIDS program was originally backed by $1.5 million from unspent Congressional funds, but because the government is prohibited from fundraising, the other anesthesiology groups and universities involved with the program will have to spearhead that effort. [5]

    While the IARS primarily is in charge of the fundraising and the distribution of those funds, Michael K. Cahalan, M.D., chair of anesthesiology at the University of Utah School of Medicine in Salt Lake City and the IARS liaison to SAFEKIDS, said the society does not plan to raise membership dues in order to fund the research.

    The FDA has said the program’s first findings are expected to be available within two years. [7]

    [1] “FDA to Study Anesthesia Risks in Pediatrics.” Anesthesiology News , Volume 35:5. May 2009.
    [2] “FDA Launches SAFEKIDS Initiative with Academic and Clinical Partners.” FDA News Release. March 13, 2009.
    [3] “FDA to Study Anesthesia Risks in Pediatrics.” Anesthesiology News , Volume 35:5. May 2009.
    [4]  Ibid.
    [5]  Ibid.
    [6]  Ibid.
    [7] “FDA Launches SAFEKIDS Initiative with Academic and Clinical Partners.” FDA News Release. March 13, 2009.

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