SOURCE: SmartTots


August 29, 2011 20:04 ET

Dr. Mike Roizen Takes SmartTots to India

Roizen Presents Global Pediatric Safety Concern to Anesthesiologists From Eight Countries

SAN FRANCISCO, CA--(Marketwire - Aug 29, 2011) - Dr. Mike Roizen, Chair of the SmartTots Executive Board, traveled to Bengaluru, India last week to present a key session dedicated to pediatric anesthesia neurotoxicity. Anesthesiologists from eight countries, including Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan and Sri Lanka, convened at the Bangalore International Exhibit Center Saturday to hear Dr. Roizen discuss recent outcomes and ongoing research efforts related to the safe use of anesthetics in young children.

Dr. Roizen highlighted findings from studies conducted by the United States Food and Drug Administration's National Center for Toxicological Research (NCTR) and several Western universities with an emphasis on the evolving SmartTots research agenda. He referenced early rodent and recent monkey data -- all of which demonstrate neurotoxicity as the result of anesthetic exposure during early brain development.

Among presented outcomes were data generated by NCTR's ongoing investigations in the rhesus monkey. As indicated in the March-April issue of Neurotoxicology and Teratology, a single 24-hour episode of ketamine, administered during a sensitive period of brain development, results in long-lasting and subsequent cognitive deficits in nonhuman primates.

"The results demonstrated in the animal studies raise valid concerns regarding the safety of commonly used anesthetics," said Dr. Roizen. "The animal data cannot, and should not, be ignored."

Dr. Roizen reminded attendees the animal data alone are not sufficient enough to warrant changing clinical practice. He stressed the need for additional research studies to definitively determine the clinical implications of the animal data -- whether similar effects could occur in infants and young children.

"The safety of anesthetics administered to our children is not an issue confined within the United States borders," said Dr. Roizen. "This is a global issue, affecting the practice of anesthesiologists around the world, and it is important we work together to ensure the safety of our treatments."

Dr. Roizen's presentation was made possible by the 9th Congress of the SAARC-AA (South Asian Association for Regional Cooperation Association of Anaesthesiologists), hosted and organized by the Indian Society of Anaesthesiologists (ISA).

"SmartTots is grateful for, and encouraged by, the support of both the SAARC-AA and the ISA," said Dr. Roizen. "We look forward to working with our South Asian colleagues in the near future."

About SmartTots

SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots) is a Public-Private Partnership between the U.S. Food and Drug Administration (FDA) and the International Anesthesia Research Society (IARS) designed to close research gaps related to the effects of anesthetics on the developing brain, and ensure the safety of infants and young children undergoing anesthetics in medical procedures. Findings from SmartTots research studies will determine the safety of commonly used anesthetics, establish new practice guidelines, and potentially foster the development of new, safer anesthetics and sedatives. For more information, visit

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