US FDA launches SAFEKIDS Initiative
The use of anesthetics and sedatives is necessary in performing certain medical interventions, from a simple tooth extraction to more complicated surgical procedures. However, there have been concerns about the effects of these medications on children’s developing brain. Studies in animals have linked sedative and anesthetic use to memory problems, learning deficits and other neurodegenerative changes in the central nervous system. However, no data on human patients are available even though millions of children receive these drugs each year.
It is for this reason that the regulatory body US FDA launched the multi-year project Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS). The project involves collaboration with academic and clinical partners who will look into filling major gaps in scientific information about the safe use of anesthetics and sedatives. It is hoped that the first set of data will be available within the next two years. The SAFEKIDS researcher partners are:
- 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.